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1.
Trials ; 22(1): 172, 2021 Mar 01.
Article in English | MEDLINE | ID: covidwho-1622253

ABSTRACT

OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. TRIAL DESIGN: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. PARTICIPANTS: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. INCLUSION CRITERIA: Subjects will be eligible for the trial if they meet all of the following criteria: 1. Adult (≥18 years of age) at time of enrolment; 2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing); 3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy; 4. Moderate or severe ARDS according to Berlin criteria: • Moderate - PaO2/FiO2 100-200 mmHg; • Severe - PaO2/FiO2 < 100 mmHg; 5. Admission to ICU in the last 24 hours. EXCLUSION CRITERIA: Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at least 1 week after the last dose of dexamethasone (sexual abstinence is considered an adequate contraception method); 5. End-of-life decision or patient is expected to die within next 24 hours; 6. Decision not to intubate or ceilings of care in place; 7. Immunosuppression and/or immunosuppressive drugs in medical history: a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days; b) Systemic corticosteroid use before hospitalization; c) Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrolment; d) Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock); 8. Current haematological or generalized solid malignancy; 9. Any contraindication for corticosteroid administration, e.g. • intractable hyperglycaemia; • active gastrointestinal bleeding; • adrenal gland disorders; • presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. Cardiac arrest before ICU admission; 11. Participation in another interventional trial in the last 30 days. INTERVENTION AND COMPARATOR: Dexamethasone solution for injection/infusion is the investigational medicinal product as well as the comparator. The trial will assess two doses, 20 mg (investigational) vs 6 mg (comparator). Patients in the intervention group will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. Patients in the control group will receive dexamethasone 6 mg day 1-10. All authorized medicinal products containing dexamethasone in the form of solution for i.v. injection/infusion can be used. MAIN OUTCOMES: Primary endpoint: Number of ventilator-free days (VFDs) at 28 days after randomisation, defined as being alive and free from mechanical ventilation. SECONDARY ENDPOINTS: a) Mortality from any cause at 60 days after randomisation; b) Dynamics of inflammatory marker (C-Reactive Protein, CRP) change from Day 1 to Day 14; c) WHO Clinical Progression Scale at Day 14; d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge; e) Independence at 90 days after randomisation assessed by Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days through telephone structured interviews using the Barthel Index. RANDOMISATION: Randomisation will be carried out within the electronic case report form (eCRF) by the stratified permuted block randomisation method. Allocation sequences will be prepared by a statistician independent of the study team. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomisation process. The following stratification factors will be applied: • Age <65 and ≥ 65; • Charlson Comorbidity index (CCI) <3 and ≥3; • CRP <150 mg/L and ≥150 mg/L • Trial centre. Patients will be randomised in a 1 : 1 ratio into one of the two treatment arms. Randomisation through the eCRF will be available 24 hours every day. BLINDING (MASKING): This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is calculated to detect the difference of 3 VFDs at 28 days (primary efficacy endpoint) between the two treatment arms with a two-sided type I error of 0.05 and power of 80%. Based on data from a multi-centre randomised controlled trial in COVID-19 ARDS patients in Brazil and a multi-centre observational study from French and Belgian ICUs regarding moderate to severe ARDS related to COVID-19, investigators assumed a standard deviation of VFD at 28 days as 9. Using these assumptions, a total of 142 patients per treatment arm would be needed. After adjustment for a drop-out rate, 150 per treatment arm (300 patients per study) will be enrolled. TRIAL STATUS: This is protocol version 1.1, 15.01.2021. The trial is due to start on 2 February 2021 and recruitment is expected to be completed by December 2021. TRIAL REGISTRATION: The study protocol was registered on EudraCT No.:2020-005887-70, and on December 11, 2020 on ClinicalTrials.gov (Title: Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)) Identifier: NCT04663555 with a last update posted on February 1, 2021. FULL PROTOCOL: The full protocol (version 1.1) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the standard formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
COVID-19/therapy , Dexamethasone/administration & dosage , Glucocorticoids/administration & dosage , Respiration, Artificial , Respiratory Distress Syndrome/therapy , COVID-19/complications , Clinical Trials, Phase II as Topic , Disease Progression , Dose-Response Relationship, Drug , Equivalence Trials as Topic , Humans , Length of Stay , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Respiratory Distress Syndrome/etiology , SARS-CoV-2
2.
Turk J Med Sci ; 51(4): 1665-1674, 2021 08 30.
Article in English | MEDLINE | ID: covidwho-1526879

ABSTRACT

Background/aim: Coronavirus disease 2019 (COVID-19) is a disease with a high rate of progression to critical illness. However, the predictors of mortality in critically ill patients admitted to the intensive care unit (ICU) are not yet well understood. In this study, we aimed to investigate the risk factors associated with ICU mortality in our hospital. Materials and methods: In this single-centered retrospective study, we enrolled 86 critically ill adult patients with COVID-19 admitted to ICU of Dokuz Eylül University Hospital (Izmir, Turkey) between 18 March 2020 and 31 October 2020. Data on demographic information, preexisting comorbidities, treatments, the laboratory findings at ICU admission, and clinical outcomes were collected. The chest computerized tomography (CT) of the patients were evaluated specifically for COVID-19 and CT score was calculated. Data of the survivors and nonsurvivors were compared with survival analysis to identify risk factors of mortality in the ICU. Results: The mean age of the patients was 71.1 ± 14.1 years. The patients were predominantly male. The most common comorbidity in patients was hypertension. ICU mortality was 62.8%. Being over 60 years old, CT score > 15, acute physiology and chronic health evaluation (APACHE) II score ≥ 15, having dementia, treatment without favipiravir, base excess in blood gas analysis ≤ ­2.0, WBC > 10,000/mm3, D-dimer > 1.6 µg/mL, troponin > 24 ng/L, Na ≥ 145 mmol/L were considered to link with ICU mortality according to Kaplan­Meier curves (log-rank test, p < 0.05). The APACHE II score (HR: 1.055, 95% CI: 1.021­1.090) and chest CT score (HR: 2.411, 95% CI:1.193­4.875) were associated with ICU mortality in the cox proportional-hazard regression model adjusted for age, dementia, favipiravir treatment and troponin. Howewer, no difference was found between survivors and nonsurvivors in terms of intubation timing. Conclusions: COVID-19 patients have a high ICU admission and mortality rate. Studies in the ICU are also crucial in this respect. In our study, we investigated the ICU mortality risk factors of COVID-19 patients. We determined a predictive mortality model consisting of APACHE II score and chest CT score. It was thought that this feasible and practical model would assist in making clinical decisions.


Subject(s)
COVID-19/diagnostic imaging , COVID-19/mortality , Critical Care/methods , Hospital Mortality , Intubation, Intratracheal/methods , Tomography, X-Ray Computed/methods , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Intensive Care Units , Intubation, Intratracheal/statistics & numerical data , Lung/diagnostic imaging , Male , Middle Aged , Retrospective Studies , Risk Factors , SARS-CoV-2 , Survival Analysis , Time Factors , Turkey/epidemiology , Young Adult
3.
J Infect ; 83(2): e1-e3, 2021 08.
Article in English | MEDLINE | ID: covidwho-1386044

ABSTRACT

AIM: to compare clinical features and outcome of children with severe acute lower respiratory infection (ALRI) with or without SARS-CoV-2 infection admitted to Paediatric Intensive Care Unit (PICU). METHODS: for this retrospective cohort study, all children aged<17 years admitted with severe ALRI at a PICU, in Salvador, Brazil were evaluated. Investigation of SARS-CoV-2 infection was performed by real-time reverse-transcription PCR. Clinical data, physical findings upon admission and outcome were registered. Patients were categorized by with or without SARS-Cov-2 infection. Outcomes were death and invasive mechanical ventilation (IMV). RESULTS: we enrolled 210 patients, whose median age was 2.8 years (IQR: 7.1 months-6.2 years). IMV was used in 33 (15.7%; 95%CI 11.3%-21.1%) patients. Eight (3.8%; 95%CI 1.8%-7.1%) cases died. 62 patients (29.5%) tested positive for SARS-CoV-2. Male gender (67.7% vs. 52.7%, P = 0.045) and sickle cell disease (6.5% vs. 0%, P = 0.007) were associated with SARS-CoV-2 infection. Wheezing upon admission was more common in patients without SARS-CoV-2 infection (38.5% vs. 21.0%, P = 0.01). IMV was more frequent among patients with SARS-CoV-2 infection (25.8% vs. 11.5%, P = 0.009) as well as death (8.1% vs. 2.0%, P = 0.05). CONCLUSION: children with severe ALRI infection with SARS-CoV-2 need IMV more frequently than those without it.


Subject(s)
COVID-19 , SARS-CoV-2 , Brazil/epidemiology , Child , Child, Preschool , Humans , Male , Respiration, Artificial , Retrospective Studies
4.
BMC Res Notes ; 14(1): 20, 2021 Jan 09.
Article in English | MEDLINE | ID: covidwho-1388819

ABSTRACT

OBJECTIVE: We aimed to characterize the effects of prone positioning on respiratory mechanics and oxygenation in invasively ventilated patients with SARS-CoV-2 ARDS. RESULTS: This was a prospective cohort study in the Intensive Care Unit (ICU) of a tertiary referral centre. We included 20 consecutive, invasively ventilated patients with laboratory confirmed SARS-CoV-2 related ARDS who underwent prone positioning in ICU as part of their management. The main outcome was the effect of prone positioning on gas exchange and respiratory mechanics. There was a median improvement in the PaO2/FiO2 ratio of 132 in the prone position compared to the supine position (IQR 67-228). We observed lower PaO2/FiO2 ratios in those with low (< median) baseline respiratory system static compliance, compared to those with higher (> median) static compliance (P < 0.05). There was no significant difference in respiratory system static compliance with prone positioning. Prone positioning was effective in improving oxygenation in SARS-CoV-2 ARDS. Furthermore, poor respiratory system static compliance was common and was associated with disease severity. Improvements in oxygenation were partly due to lung recruitment. Prone positioning should be considered in patients with SARS-CoV-2 ARDS.


Subject(s)
COVID-19/therapy , Lung/metabolism , Prone Position , COVID-19/metabolism , Cohort Studies , Humans , Male , Middle Aged , Oxygen/metabolism , Prospective Studies , Respiration, Artificial
5.
Trials ; 22(1): 288, 2021 Apr 19.
Article in English | MEDLINE | ID: covidwho-1388815

ABSTRACT

OBJECTIVES: The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6). Secondary objectives are to determine the effects of intravenous Prolastin® on important clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs). TRIAL DESIGN: Phase 2, randomised, double-blind, placebo-controlled, pilot trial. PARTICIPANTS: The study will be conducted in Intensive Care Units in hospitals across Ireland. Patients with a laboratory-confirmed diagnosis of SARS-CoV-2-infection, moderate to severe ARDS (meeting Berlin criteria for a diagnosis of ARDS with a PaO2/FiO2 ratio <200 mmHg), >18 years of age and requiring invasive or non-invasive mechanical ventilation. All individuals meeting any of the following exclusion criteria at baseline or during screening will be excluded from study participation: more than 96 hours has elapsed from onset of ARDS; age < 18 years; known to be pregnant or breastfeeding; participation in a clinical trial of an investigational medicinal product (other than antibiotics or antivirals) within 30 days; major trauma in the prior 5 days; presence of any active malignancy (other than nonmelanoma skin cancer) which required treatment within the last year; WHO Class III or IV pulmonary hypertension; pulmonary embolism prior to hospital admission within past 3 months; currently receiving extracorporeal life support (ECLS); chronic kidney disease receiving dialysis; severe chronic liver disease with Child-Pugh score > 12; DNAR (Do Not Attempt Resuscitation) order in place; treatment withdrawal imminent within 24 hours; Prisoners; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; IgA deficiency. INTERVENTION AND COMPARATOR: Intervention: Either a once weekly intravenous infusion of Prolastin® at 120mg/kg of body weight for 4 weeks or a single dose of Prolastin® at 120mg/kg of body weight intravenously followed by once weekly intravenous infusion of an equal volume of 0.9% sodium chloride for a further 3 weeks. Comparator (placebo): An equal volume of 0.9% sodium chloride intravenously once per week for four weeks. MAIN OUTCOMES: The primary effectiveness outcome measure is the change in plasma concentration of IL-6 at 7 days as measured by ELISA. Secondary outcomes include: safety and tolerability of Prolastin® in the respective groups (as defined by the number of SAEs and AEs); PaO2/FiO2 ratio; respiratory compliance; sequential organ failure assessment (SOFA) score; mortality; time on ventilator in days; plasma concentration of alpha-1 antitrypsin (AAT) as measured by nephelometry; plasma concentrations of interleukin-1ß (IL-1ß), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TNF receptor 1 (sTNFR1, a surrogate marker for TNF-α) as measured by ELISA; development of shock; acute kidney injury; need for renal replacement therapy; clinical relapse, as defined by the need for readmission to the ICU or a marked decline in PaO2/FiO2 or development of shock or mortality following a period of sustained clinical improvement; secondary bacterial pneumonia as defined by the combination of radiographic findings and sputum/airway secretion microscopy and culture. RANDOMISATION: Following informed consent/assent patients will be randomised. The randomisation lists will be prepared by the study statistician and given to the unblinded trial personnel. However, the statistician will not be exposed to how the planned treatment will be allocated to the treatment codes. Randomisation will be conducted in a 1:1:1 ratio, stratified by site and age. BLINDING (MASKING): The investigator, treating physician, other members of the site research team and patients will be blinded to treatment allocation. The clinical trial pharmacy personnel and research nurses will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set to maintain blinding. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 36 patients will be recruited and randomised in a 1:1:1 ratio to each of the trial arms. TRIAL STATUS: In March 2020, version 1.0 of the trial protocol was submitted to the local research ethics committee (REC), Health Research Consent Declaration Committee (HRCDC) and the Health Products regulatory Authority (HPRA). REC approval was granted on April 1st 2020, HPRA approval was granted on April 24th 2020 and the HRCDC provided a conditional declaration on April 17th 2020. In July 2020 a substantial amendment (version 2.0) was submitted to the REC, HRCDC and HPRA. Protocol changes in this amendment included: the addition of trial sites; extending the duration of the trial to 12 months from 3 months; removal of inclusion criteria requiring the need for vasopressors; amendment of randomisation schedule to stratify by age only and not BMI and sex; correction of grammatical error in relation to infusion duration; to allow for inclusion of subjects who may have been enrolled in a clinical trial involving either antibiotics or anti-virals in the past 30 days; to allow for inclusion of subjects who may be currently enrolled in a clinical trial involving either antibiotics or anti-virals; to remove the need for exclusion based on alpha-1 antitrypsin phenotype; removal of mandatory isoelectric focusing of plasma to confirm Pi*MM status at screening; removal of need for mandatory echocardiogram at screening; amendment on procedures around plasma analysis to reflect that this will be conducted at the central site laboratory (as trial is multi-site and no longer single site); wording amended to reflect that interim analysis of cytokine levels taken at 7 days may be conducted. HRCDC approved version 2.0 on September 14th 2020, and HPRA approved on October 22nd 2020. REC approved the substantial amendment on November 23rd. In November 2020, version 3.0 of the trial protocol was submitted to the REC and HPRA. The rationale for this amendment was to allow for patients with moderate to severe ARDS from SARS-CoV-2 with non-invasive ventilation. HPRA approved this amendment on December 1st 2020 and the REC approved the amendment on December 8th 2020. Patient recruitment commenced in April 2020 and the last patient will be recruited to the trial in April 2021. The last visit of the last patient is anticipated to occur in April 2021. At time of writing, patient recruitment is now complete, however follow-up patient visits and data collection are ongoing. TRIAL REGISTRATION: EudraCT 2020-001391-15 (Registered 31 Mar 2020). FULL PROTOCOL: The full protocol (version 3.0 23.11.2020) is attached as an additional file accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).


Subject(s)
COVID-19/drug therapy , Respiratory Distress Syndrome/drug therapy , alpha 1-Antitrypsin/therapeutic use , Double-Blind Method , Humans , Ireland , Pilot Projects , Plasma , Randomized Controlled Trials as Topic , Respiratory Distress Syndrome/chemically induced , Respiratory Distress Syndrome/diagnosis , alpha 1-Antitrypsin/administration & dosage
6.
Gac Med Mex ; 157(1): 97-101, 2021.
Article in English | MEDLINE | ID: covidwho-1328412

ABSTRACT

INTRODUCTION: COVID-19-associated mortality in patients who require mechanical ventilation is unknown in the Mexican population. OBJECTIVE: To describe the characteristics of Mexican patients with COVID-19 who required mechanical ventilation. METHODS: Observational cohort study carried out in an intensive care unit from March 25 to July 17, 2020. Data were obtained from a prospective database and electronic medical records, and were analyzed with the chi-square test, Fisher's exact test or Mann-Whitney's U-test. RESULTS: One hundred patients required mechanical ventilation; median age was 56 years, 31 % were females and 97 % were Latin American. Most common comorbidities were obesity (36 %), diabetes (26 %), hypertension (20 %), and chronic or end-stage kidney disease (10 %). At the end of the analysis, 11 patients remained in the ICU, 31 had been discharged alive and 58 (65.2 %) died; survivors were younger, had lower scores on severity and organ dysfunction scales, lower levels of C-reactive protein at ICU admission, were less likely to receive hemodialysis and vasopressors, and had longer hospital and ICU stays. CONCLUSIONS: This study adds information on the presentation and results of SARS-CoV-2-infected patients who require mechanical ventilation.


INTRODUCCIÓN: La mortalidad por COVID-19 en quienes requieren ventilación mecánica se desconoce en la población mexicana. OBJETIVO: Describir las características de pacientes mexicanos con COVID-19 que requirieron ventilación mecánica. MÉTODOS: Estudio de cohorte observacional en una unidad de terapia intensiva, del 25 de marzo al 17 de julio de 2020. Los datos se obtuvieron de una base de datos prospectiva y de registros clínicos electrónicos; fueron analizados con c2, prueba exacta de Fisher o prueba U de Mann-Whitney. RESULTADOS: Cien pacientes recibieron ventilación mecánica, la edad media fue de 56 años, 31 % era del sexo femenino y 97 %, latinoamericano. Las comorbilidades más comunes fueron obesidad (36 %), diabetes (26 %), hipertensión (20 %) y enfermedad renal crónica o renal terminal (10 %). Al término del análisis, 11 pacientes permanecían en la UCI, 31 egresaron vivos y 58 (65.2 %) fallecieron; los sobrevivientes fueron más jóvenes, con menores puntuación en las escalas de gravedad y disfunción orgánica, menores niveles de proteína C reactiva al ingreso a la UCI, menor propensión a hemodiálisis, necesidad de, necesidad de vasopresores y con mayor estancia hospitalaria y en la UCI. CONCLUSIONES: Este estudio agrega información sobre la presentación y resultados de pacientes con ventilación mecánica infectados con SARS-CoV-2.


Subject(s)
COVID-19/mortality , COVID-19/therapy , Respiration, Artificial , Aged , Cohort Studies , Female , Humans , Male , Mexico/epidemiology , Middle Aged
7.
Lancet Healthy Longev ; 2(3): e163-e170, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1284653

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, the scarcity of resources has necessitated triage of critical care for patients with the disease. In patients aged 65 years and older, triage decisions are regularly based on degree of frailty measured by the Clinical Frailty Scale (CFS). However, the CFS could also be useful in patients younger than 65 years. We aimed to examine the association between CFS score and hospital mortality and between CFS score and admission to intensive care in adult patients of all ages with COVID-19 across Europe. METHODS: This analysis was part of the COVID Medication (COMET) study, an international, multicentre, retrospective observational cohort study in 63 hospitals in 11 countries in Europe. Eligible patients were aged 18 years and older, had been admitted to hospital, and either tested positive by PCR for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or were judged to have a high clinical likelihood of having SARS-CoV-2 infection by the local COVID-19 expert team. CFS was used to assess level of frailty: fit (CFS1-3), mildly frail (CFS4-5), or frail (CFS6-9). The primary outcome was hospital mortality. The secondary outcome was admission to intensive care. Data were analysed using a multivariable binary logistic regression model adjusted for covariates (age, sex, number of drugs prescribed, and type of drug class as a proxy for comorbidities). FINDINGS: Between March 30 and July 15, 2020, 2434 patients (median age 68 years [IQR 55-77]; 1480 [61%] men, 954 [30%] women) had CFS scores available and were included in the analyses. In the total sample and in patients aged 65 years and older, frail patients and mildly frail patients had a significantly higher risk of hospital mortality than fit patients (total sample: CFS6-9 vs CFS1-3 odds ratio [OR] 2·71 [95% CI 2·04-3·60], p<0·0001 and CFS4-5 vs CFS1-3 OR 1·54 [1·16-2·06], p=0·0030; age ≥65 years: CFS6-9 vs CFS1-3 OR 2·90 [2·12-3·97], p<0·0001 and CFS4-5 vs CFS1-3 OR 1·64 [1·20-2·25], p=0·0020). In patients younger than 65 years, an increased hospital mortality risk was only observed in frail patients (CFS6-9 vs CFS1-3 OR 2·22 [1·08-4·57], p=0·030; CFS4-5 vs CFS1-3 OR 1·08 [0·48-2·39], p=0·86). Frail patients had a higher incidence of admission to intensive care than fit patients (CFS6-9 vs CFS1-3 OR 1·54 [1·21-1·97], p=0·0010), whereas mildly frail patients had a lower incidence than fit patients (CFS4-5 vs CFS1-3 OR 0·71 [0·55-0·92], p=0·0090). Among patients younger than 65 years, frail patients had an increased incidence of admission to intensive care (CFS6-9 vs CFS1-3 OR 2·96 [1·98-4·43], p<0·0001), whereas mildly frail patients had no significant difference in incidence compared with fit patients (CFS4-5 vs CFS1-3 OR 0·93 [0·63-1·38], p=0·72). Among patients aged 65 years and older, frail patients had no significant difference in the incidence of admission to intensive care compared with fit patients (CFS6-9 vs CFS1-3 OR 1·27 [0·92-1·75], p=0·14), whereas mildly frail patients had a lower incidence than fit patients (CFS4-5 vs CFS1-3 OR 0·66 [0·47-0·93], p=0·018). INTERPRETATION: The results of this study suggest that CFS score is a suitable risk marker for hospital mortality in adult patients with COVID-19. However, treatment decisions based on the CFS in patients younger than 65 years should be made with caution. FUNDING: LOEY Foundation.

8.
BMC Med Ethics ; 22(1): 73, 2021 06 17.
Article in English | MEDLINE | ID: covidwho-1277937

ABSTRACT

BACKGROUND: The COVID-19 pandemic has created ethical challenges for intensive care unit (ICU) professionals, potentially causing moral distress. This study explored the levels and causes of moral distress and the ethical climate in Dutch ICUs during COVID-19. METHODS: An extended version of the Measurement of Moral Distress for Healthcare Professionals (MMD-HP) and Ethical Decision Making Climate Questionnaire (EDMCQ) were online distributed among all 84 ICUs. Moral distress scores in nurses and intensivists were compared with the historical control group one year before COVID-19. RESULTS: Three hundred forty-five nurses (70.7%), 40 intensivists (8.2%), and 103 supporting staff (21.1%) completed the survey. Moral distress levels were higher for nurses than supporting staff. Moral distress levels in intensivists did not differ significantly from those of nurses and supporting staff. "Inadequate emotional support for patients and their families" was the highest-ranked cause of moral distress for all groups of professionals. Of all factors, all professions rated the ethical climate most positively regarding the culture of mutual respect,  ethical awareness and support. "Culture of not avoiding end-of-life-decisions" and "Self-reflective and empowering leadership" received the lowest mean scores. Moral distress scores during COVID-19 were significantly lower for ICU nurses (p < 0.001) and intensivists (p < 0.05) compared to one year prior. CONCLUSION: Levels and causes of moral distress vary between ICU professionals and differ from the historical control group. Targeted interventions that address moral distress during a crisis are desirable to improve the mental health and retention of ICU professionals and the quality of patient care.


Subject(s)
COVID-19 , Attitude of Health Personnel , Critical Care , Humans , Intensive Care Units , Morals , Pandemics , SARS-CoV-2 , Stress, Psychological , Surveys and Questionnaires
9.
J Intensive Care Med ; 36(8): 963-971, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1273202

ABSTRACT

In the first months of the COVID-19 pandemic in Europe, many patients were treated in hospitals using mechanical ventilation. However, due to a shortage of ICU ventilators, hospitals worldwide needed to deploy anesthesia machines for ICU ventilation (which is off-label use). A joint guidance was written to apply anesthesia machines for long-term ventilation. The goal of this research is to retrospectively evaluate the differences in measurable ventilation parameters between the ICU ventilator and the anesthesia machine as used for COVID-19 patients. In this study, we included 32 patients treated in March and April 2020, who had more than 3 days of mechanical ventilation, either in the regular ICU with ICU ventilators (Hamilton S1), or in the temporary emergency ICU with anesthetic ventilators (Aisys, GE). The data acquired during regular clinical treatment was collected from the Patient Data Management Systems. Available ventilation parameters (pressures and volumes: PEEP, Ppeak, Pinsp, Vtidal), monitored parameters EtCO2, SpO2, derived compliance C, and resistance R were processed and analyzed. A sub-analysis was performed to compare closed-loop ventilation (INTELLiVENT-ASV) to other ventilation modes. The results showed no major differences in the compared parameters, except for Pinsp. PEEP was reduced over time in the with Hamilton treated patients. This is most likely attributed to changing clinical protocol as more clinical experience and literature became available. A comparison of compliance between the 2 ventilators could not be made due to variances in the measurement of compliance. Closed loop ventilation could be used in 79% of the time, resulting in more stable EtCO2. From the analysis it can be concluded that the off-label usage of the anesthetic ventilator in our hospital did not result in differences in ventilation parameters compared to the ICU treatment in the first 4 days of ventilation.


Subject(s)
Anesthesiology/instrumentation , COVID-19 , Respiration, Artificial/methods , Ventilators, Mechanical , Aged , COVID-19/therapy , Europe , Humans , Intensive Care Units , Middle Aged , Pandemics , Retrospective Studies , Ventilators, Mechanical/supply & distribution
10.
J Clin Nurs ; 31(5-6): 601-611, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1268127

ABSTRACT

BACKGROUND: Faced with this critical situation and directly involved in the treatment and care of COVID-19 patients, front-line healthcare workers are at high risk in terms of mental health symptoms. AIMS AND OBJECTIVES: To determine the stress, anxiety, depression, and insomnia levels of intensive care nurses during the pandemic with a structural equation model. DESIGN: A multi-site survey study. METHODS: The study was performed with 194 nurses working in the intensive care units of five hospitals in Istanbul in July 2020. Data were collected using the Depression Anxiety Stress-21 Scale and Insomnia Severity Index electronically. The data were evaluated with descriptive statistics in SPSS package program. In order to test the structural model and hypotheses of the research, path analysis was performed with LISREL statistical software program. A validation study for the suitability of these scales to the study sample was done by the researchers using the confirmatory factor analysis method. The study conforms to the TREND checklist. RESULTS: In this study, the majority of the intensive care nurses had moderate to extremely severe depression (65.5%), anxiety (58.3%) and stress (72.3%) scores; in addition, 39.7% of the nurses experienced moderate or severe insomnia. Within the framework of a structural model; the effects of stress, anxiety and insomnia on depression, which is the dependent variable, were found to be statistically significant (p < .001). CONCLUSIONS: It was found that the majority of the intensive care nurses fighting COVID-19 on the front-line experienced stress, anxiety, depression and insomnia at levels ranging from moderate to extremely severe; in addition, it was determined that there is a positive relationship between stress, anxiety, insomnia and depression. RELEVANCE TO CLINICAL PRACTICE: This study, in which we have determined the mental health symptoms and insomnia levels of intensive care nurses, who are in the front-line during the COVID-19 pandemic, constitutes the scientific basis for the effective coping strategies that the authorities will take in this subject.


Subject(s)
COVID-19 , Sleep Initiation and Maintenance Disorders , Anxiety/epidemiology , Critical Care , Cross-Sectional Studies , Depression/epidemiology , Humans , Mental Health , Pandemics , SARS-CoV-2 , Sleep Initiation and Maintenance Disorders/epidemiology
11.
Crit Care ; 25(1): 186, 2021 06 01.
Article in English | MEDLINE | ID: covidwho-1255959

ABSTRACT

BACKGROUND: In acute respiratory distress syndrome (ARDS), extravascular lung water index (EVLWi) and pulmonary vascular permeability index (PVPI) measured by transpulmonary thermodilution reflect the degree of lung injury. Whether EVLWi and PVPI are different between non-COVID-19 ARDS and the ARDS due to COVID-19 has never been reported. We aimed at comparing EVLWi, PVPI, respiratory mechanics and hemodynamics in patients with COVID-19 ARDS vs. ARDS of other origin. METHODS: Between March and October 2020, in an observational study conducted in intensive care units from three university hospitals, 60 patients with COVID-19-related ARDS monitored by transpulmonary thermodilution were compared to the 60 consecutive non-COVID-19 ARDS admitted immediately before the COVID-19 outbreak between December 2018 and February 2020. RESULTS: Driving pressure was similar between patients with COVID-19 and non-COVID-19 ARDS, at baseline as well as during the study period. Compared to patients without COVID-19, those with COVID-19 exhibited higher EVLWi, both at the baseline (17 (14-21) vs. 15 (11-19) mL/kg, respectively, p = 0.03) and at the time of its maximal value (24 (18-27) vs. 21 (15-24) mL/kg, respectively, p = 0.01). Similar results were observed for PVPI. In COVID-19 patients, the worst ratio between arterial oxygen partial pressure over oxygen inspired fraction was lower (81 (70-109) vs. 100 (80-124) mmHg, respectively, p = 0.02) and prone positioning and extracorporeal membrane oxygenation (ECMO) were more frequently used than in patients without COVID-19. COVID-19 patients had lower maximal lactate level and maximal norepinephrine dose than patients without COVID-19. Day-60 mortality was similar between groups (57% vs. 65%, respectively, p = 0.45). The maximal value of EVLWi and PVPI remained independently associated with outcome in the whole cohort. CONCLUSION: Compared to ARDS patients without COVID-19, patients with COVID-19 had similar lung mechanics, but higher EVLWi and PVPI values from the beginning of the disease. This was associated with worse oxygenation and with more requirement of prone positioning and ECMO. This is compatible with the specific lung inflammation and severe diffuse alveolar damage related to COVID-19. By contrast, patients with COVID-19 had fewer hemodynamic derangement. Eventually, mortality was similar between groups. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ClinicalTrials.gov (NCT04337983). Registered 30 March 2020-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04337983 .


Subject(s)
COVID-19/metabolism , Capillary Permeability , Extravascular Lung Water/metabolism , Respiratory Distress Syndrome/metabolism , Severity of Illness Index , COVID-19/complications , Hemodynamics , Humans , Lung/blood supply , Male , Middle Aged , Monitoring, Physiologic/methods , Prognosis , Pulmonary Edema/metabolism , Thermodilution
12.
Ann Intensive Care ; 11(1): 87, 2021 May 31.
Article in English | MEDLINE | ID: covidwho-1247600

ABSTRACT

BACKGROUND: Dexamethasone decreases mortality in patients with severe coronavirus disease 2019 (COVID-19) and has become the standard of care during the second wave of pandemic. Dexamethasone is an immunosuppressive treatment potentially increasing the risk of secondary hospital acquired infections in critically ill patients. We conducted an observational retrospective study in three French intensive care units (ICUs) comparing the first and second waves of pandemic to investigate the role of dexamethasone in the occurrence of ventilator-associated pneumonia (VAP) and blood stream infections (BSI). Patients admitted from March to November 2020 with a documented COVID-19 and requiring mechanical ventilation (MV) for ≥ 48 h were included. The main study outcomes were the incidence of VAP and BSI according to the use of dexamethasone. Secondary outcomes were the ventilator-free days (VFD) at day-28 and day-60, ICU and hospital length of stay and mortality. RESULTS: Among the 151 patients included, 84 received dexamethasone, all but one during the second wave. VAP occurred in 63% of patients treated with dexamethasone (DEXA+) and 57% in those not receiving dexamethasone (DEXA-) (p = 0.43). The cumulative incidence of VAP, considering death, duration of MV and late immunosuppression as competing factors was not different between groups (p = 0.59). A multivariate analysis did not identify dexamethasone as an independent risk factor for VAP occurrence. The occurrence of BSI was not different between groups (29 vs. 30%; p = 0.86). DEXA+ patients had more VFD at day-28 (9 (0-21) vs. 0 (0-11) days; p = 0.009) and a reduced ICU length of stay (20 (11-44) vs. 32 (17-46) days; p = 0.01). Mortality did not differ between groups. CONCLUSIONS: In this cohort of COVID-19 patients requiring invasive MV, dexamethasone was not associated with an increased incidence of VAP or BSI. Dexamethasone might not explain the high rates of VAP and BSI observed in critically ill COVID-19 patients.

13.
BMJ Open ; 11(5): e049437, 2021 05 25.
Article in English | MEDLINE | ID: covidwho-1243715

ABSTRACT

OBJECTIVES: Concern about trainee work-related well-being has been raised in recent years and is the subject of several reviews, reports and research studies. This study aimed to understand the experiences of trainees working in a large intensive care unit during the first surge of the COVID-19 pandemic from an educational and operational perspective in order to highlight what worked and what could be improved. DESIGN: A qualitative study using peer-to-peer semistructured interviews, developed using appreciative inquiry methodology, was conducted during July 2020. Responses were analysed using a thematic analysis technique. SETTING: A large, tertiary intensive care unit in the UK. PARTICIPANTS: All trainees in anaesthesia and intensive care working on the intensive care unit during the first surge were invited to participate. RESULTS: Forty interviews were conducted and four over-arching themes were identified. These were: feeling safe and supported; physical demands; the emotional burden of caring; and a sense of fulfilment, value and personal development. Positive aspects of the organisational response to the pandemic included communication, personal protective equipment supply, team working and well-being support. Suggestions for improvement focused on rest facilities, rota patterns and hierarchies, creating opportunities for reflection and ensuring continued educational and training opportunities despite operational demands. CONCLUSIONS: Trainees described opportunities for learning and fulfilment, as well as challenges, in working through a pandemic. Trainees described their needs and how well these were met during the pandemic. Ideas for improvement most frequently related to basic needs including safety and fatigue, but suggestions also related to supporting learning and development. The appreciative inquiry methodology of the project facilitated effective reflection on positive aspects of trainee experiences.


Subject(s)
COVID-19 , Pandemics , Critical Care , Humans , Personal Protective Equipment , Qualitative Research , SARS-CoV-2
14.
Health Sci Rep ; 4(2): e302, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1242722

ABSTRACT

BACKGROUND: Chest radiography (CXR) and computerized tomography (CT) are the standard methods for lung imaging in diagnosing COVID-19 pneumonia in the intensive care unit (ICU), despite their limitations. This study aimed to assess the performance of bedside lung ultrasound examination by a critical care physician for the diagnosis of COVID-19 pneumonia during acute admission to the ICU. METHOD: This was an observational, prospective, single-center study conducted in the intensive care unit of Adan General Hospital from April 10, 2020, to May 26, 2020. The study included adults with suspicion of COVID-19 Infection who were transferred to the ICU. Patients were admitted to the ICU directly from the ED after reverse transcriptase-polymerase chain reaction (RT-PCR) swabs were sent to the central virology laboratory in Kuwait, and the results were released 16 to 24 hours after the time of admission. A certified intensivist in critical care ultrasound performed the lung ultrasound within 12 hours of the patient's admission to the ICU.The treating physician confirmed the diagnosis of COVID-19 pneumonia based on a set of clinical features, inflammatory markers, biochemical profile studies, RT-PCR test results, and CXR. RESULTS: Of 77 patients with suspected COVID-19 pneumonia, 65 (84.4%) were confirmed. The median age of the patients was 48 (31-68) years, and 51 (71%) were men.In the group of patients with confirmed COVID-19 pneumonia, LUS revealed four signs suggestive of COVID-19 pneumonia in 63 patients (96.9%) (sensitivity 96.9%, CI 85%-99.5%). Two patients presented with unilateral lobar pneumonia without other ultrasonic signs of COVID-19 pneumonia but with positive RT-PCR results. Among patients in the group without COVID-19 pneumonia who had negative RT-PCR results, 11 (91.7%) were LUS negative for COVID-19 pneumonia (specificity 91.7%, 95% CI 58.72%-99.77%). CONCLUSIONS: During the COVID-19 outbreak, LUS allows the identification of early signs of interstitial pneumonia. LUS patterns that show a combination of the four major signs offer high sensitivity and specificity compared to nasopharyngeal RT-PCR.

15.
Ann Intensive Care ; 11(1): 75, 2021 May 13.
Article in English | MEDLINE | ID: covidwho-1229003

ABSTRACT

BACKGROUND: Most hospital organizations have had to face the burden of managing the ongoing COVID-19 outbreak. One of the challenges in overcoming the influx of COVID-19 patients is controlling patient-to-staff transmission. Measuring the specific extent of ICU caregiver exposure to the virus and identifying the associated risk factors are, therefore, critical issues. We prospectively studied SARS-CoV-2 seroprevalence in the staff of a hospital in Lyon, France, several weeks after a first epidemic wave. Risk factors for the presence of SARS-CoV-2 antibodies were identified using a questionnaire survey. RESULTS: The overall seroprevalence was 9% (87/971 subjects). Greater exposure was associated with higher seroprevalence, with a rate of 3.2% [95% CI 1.1-5.2%] among non-healthcare staff, 11.3% [8.9-13.7%] among all healthcare staff, and 16.3% [12.3-20.2%] among healthcare staff in COVID-19 units. The seroprevalence was dramatically lower (3.7% [1.0-6.7%]) in the COVID-19 ICU. Risk factors for seropositivity were contact with a COVID-19-confirmed household (odds ratio (OR), 3.7 [1.8-7.4]), working in a COVID-19 unit (OR, 3.5 [2.2-5.7], and contact with a confirmed COVID-19 coworker (OR, 1.9 [1.2-3.1]). Conversely, working in the COVID-19-ICU was negatively associated with seropositivity (OR, 0.33 [0.15-0.73]). CONCLUSIONS: In this hospital, SARS-CoV-2 seroprevalence was higher among staff than in the general population. Seropositivity rates were particularly high for staff in contact with COVID-19 patients, especially those in the emergency department and in the COVID-19 unit, but were much lower in ICU staff. Clinical trial registration NCT04422977.

16.
Ann Intensive Care ; 11(1): 77, 2021 May 14.
Article in English | MEDLINE | ID: covidwho-1229002

ABSTRACT

BACKGROUND: The COVID-19 pandemic is a heavy burden in terms of health care resources. Future decision-making policies require consistent data on the management and prognosis of the older patients (> 70 years old) with COVID-19 admitted in the intensive care unit (ICU). METHODS: Characteristics, management, and prognosis of critically ill old patients (> 70 years) were extracted from the international prospective COVID-ICU database. A propensity score weighted-comparison evaluated the impact of intubation upon admission on Day-90 mortality. RESULTS: The analysis included 1199 (28% of the COVID-ICU cohort) patients (median [interquartile] age 74 [72-78] years). Fifty-three percent, 31%, and 16% were 70-74, 75-79, and over 80 years old, respectively. The most frequent comorbidities were chronic hypertension (62%), diabetes (30%), and chronic respiratory disease (25%). Median Clinical Frailty Scale was 3 (2-3). Upon admission, the PaO2/FiO2 ratio was 154 (105-222). 740 (62%) patients were intubated on Day-1 and eventually 938 (78%) during their ICU stay. Overall Day-90 mortality was 46% and reached 67% among the 193 patients over 80 years old. Mortality was higher in older patients, diabetics, and those with a lower PaO2/FiO2 ratio upon admission, cardiovascular dysfunction, and a shorter time between first symptoms and ICU admission. In propensity analysis, early intubation at ICU admission was associated with a significantly higher Day-90 mortality (42% vs 28%; hazard ratio 1.68; 95% CI 1.24-2.27; p < 0·001). CONCLUSION: Patients over 70 years old represented more than a quarter of the COVID-19 population admitted in the participating ICUs during the first wave. Day-90 mortality was 46%, with dismal outcomes reported for patients older than 80 years or those intubated upon ICU admission.

17.
Am J Health Syst Pharm ; 78(21): 1952-1961, 2021 10 25.
Article in English | MEDLINE | ID: covidwho-1228432

ABSTRACT

PURPOSE: Preliminary reports suggest that critically ill patients with coronavirus disease 2019 (COVID-19) infection requiring mechanical ventilation may have markedly increased sedation needs compared with critically ill, mechanically ventilated patients without COVID-19. We conducted a study to examine sedative use for this patient population within multiple intensive care units (ICUs) of a large academic medical center. METHODS: A retrospective, single-center cohort study of sedation practices for critically ill patients with COVID-19 during the first 10 days of mechanical ventilation was conducted in 8 ICUs at Massachusetts General Hospital, Boston, MA. The study population was a sequential cohort of 86 critically ill, mechanically ventilated patients with COVID-19. Data characterizing the sedative medications, doses, drug combinations, and duration of administration were collected daily and compared to published recommendations for sedation of critically ill patients without COVID-19. The associations between drug doses, number of drugs administered, baseline patient characteristics, and inflammatory markers were investigated. RESULTS: Among the study cohort, propofol and hydromorphone were the most common initial drug combination, with these medications being used on a given day in up to 100% and 88% of patients, respectively. The doses of sedative and analgesic infusions increased for patients over the first 10 days, reaching or exceeding the upper limits of published dosage guidelines for propofol (48% of patients), dexmedetomidine (29%), midazolam (7.7%), ketamine (32%), and hydromorphone (38%). The number of sedative and analgesic agents simultaneously administered increased over time for each patient, with more than 50% of patients requiring 3 or more agents by day 2. Compared with patients requiring 3 or fewer agents, patients requiring more than 3 agents were of younger age, had an increased body mass index, had increased serum ferritin and lactate dehydrogenase concentrations, had a lower Pao2:Fio2 (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen), and were more likely to receive neuromuscular blockade. CONCLUSION: Our study confirmed the clinical impression of elevated sedative use in critically ill, mechanically ventilated patients with COVID-19 relative to guideline-recommended sedation practices in other critically ill populations.


Subject(s)
COVID-19 , Critical Illness , Cohort Studies , Humans , Hypnotics and Sedatives , Intensive Care Units , Respiration, Artificial , Retrospective Studies , SARS-CoV-2
18.
J Infect Dev Ctries ; 15(4): 501-505, 2021 04 30.
Article in English | MEDLINE | ID: covidwho-1218643

ABSTRACT

INTRODUCTION: The role of antibiotics in the treatment in COVID-19 cases has not yet been adequately defined, and no criteria have been established for antibiotic treatment, type and duration. METHODOLOGY: This paper reports the results of an observational study on the extent of antibiotic use in 52 randomly selected patients in the intensive care unit (ICU) at the University Hospital in Pristina, Kosovo with severe forms of COVID-19. RESULTS: Antibiotics were prescribed in all the cases (52; 100%). Of the 52 patients, 1) 13 (25%) were given antibiotics before hospitalisation, 2) 49 (94.2%) during treatment in the ward and 3) 52 (100%) during treatment in the ICU. Most often, empirical antibiotics were administered in 32 cases (61.5%) to treat methicillin resistant Staphylococcus aureus (MRSA) infections, and in 23 patients (44.2%) to treat atypical pathogens. The most prescribed antibiotics were ceftriaxone/cefotaxime plus macrolide in (17 cases; 32.7%), ceftriaxone/cefotaxime in (15 cases; 28.8%), ampicillin/amoxicillin plus clavulanic acid or sulbactam (five cases; 9.6%), and quinolones (five cases; 9.6%). Imipenem was the most frequently used antibiotic in the ICU (30 cases; 57.7%), followed by ceftriaxone (28 cases; 53.8%), and piperacillin/tazobactam and fluoroquinolone (17 cases; 32.7%). In 18 cases (34.6%), three antibiotics were given simultaneously; two antibiotics in 29 cases (55.8%) and in five cases (9.6%) only one antibiotic was given. The mean duration of antibiotic treatment was 12.71 days (3-22 days; SD 4.026). CONCLUSIONS: The study showed unrestricted use of broad-spectrum antibiotics in the treatment of severe cases with COVID-19.


Subject(s)
Anti-Bacterial Agents/therapeutic use , COVID-19/drug therapy , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Comorbidity , Female , Humans , Intensive Care Units , Kosovo , Macrolides/therapeutic use , Male , Middle Aged , Respiration, Artificial , Young Adult
19.
PLoS One ; 16(4): e0251085, 2021.
Article in English | MEDLINE | ID: covidwho-1209052

ABSTRACT

BACKGROUND: The coronavirus disease (COVID-19) pandemic has severely affected African countries, specifically the countries, such as Libya, that are in constant conflict. Clinical and laboratory information, including mortality and associated risk factors in relation to hospital settings and available resources, about critically ill patients with COVID-19 in Africa is not available. This study aimed to determine the mortality and morbidity of COVID-19 patients in intensive care units (ICU) following 60 days after ICU admission, and explore the factors that influence in-ICU mortality rate. METHODS: This is a multicenter prospective observational study among COVID-19 critical care patients in 11 ICUs in Libya from May 29th to December 30th 2020. Basic demographic data, clinical characteristics, laboratory values, admission Sequential Organ Failure Assessment (SOFA) score, quick SOFA, and clinical management were analyzed. RESULT: We included 465 consecutive COVID-19 critically ill patients. The majority (67.1%) of the patients were older than 60 years, with a median (IQR) age of 69 (56.5-75); 240 (51.6%) were male. At 60 days of follow-up, 184 (39.6%) were discharged alive, while 281 (60.4%) died in the intensive care unit. The median (IQR) ICU length of stay was 7 days (4-10) and non-survivors had significantly shorter stay, 6 (3-10) days. The body mass index was 27.9 (24.1-31.6) kg/m2. At admission to the intensive care unit, quick SOFA median (IQR) score was 1 (1-2), whereas total SOFA score was 6 (4-7). In univariate analysis, the following parameters were significantly associated with increased/decreased hazard of mortality: increased age, BMI, white cell count, neutrophils, procalcitonin, cardiac troponin, C-reactive protein, ferritin, fibrinogen, prothrombin, and d-dimer levels were associated with higher risk of mortality. Decreased lymphocytes, and platelet count were associated with higher risk of mortality. Quick SOFA and total SOFA scores increase, emergency intubation, inotrope use, stress myocardiopathy, acute kidney injury, arrythmia, and seizure were associated with higher mortality. CONCLUSION: Our study reported the highest mortality rate (60.4%) among critically ill patients with COVID-19 60 days post-ICU admission. Several factors were found to be predictive of mortality, which may help to identify patients at risk of mortality during the ongoing COVID-19 pandemic.


Subject(s)
COVID-19/epidemiology , Critical Illness/epidemiology , Aged , COVID-19/blood , COVID-19/mortality , COVID-19/therapy , Critical Care , Critical Illness/mortality , Critical Illness/therapy , Female , Hospital Mortality , Humans , Intensive Care Units , Libya/epidemiology , Male , Middle Aged , Prospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Survival Analysis
20.
BMC Public Health ; 21(1): 799, 2021 04 26.
Article in English | MEDLINE | ID: covidwho-1204058

ABSTRACT

BACKGROUND: Subsequent epidemic waves have already emerged in many countries and in the absence of highly effective preventive and curative options, the role of patient characteristics on the development of outcomes needs to be thoroughly examined, especially in middle-east countries where such epidemiological studies are lacking. There is a huge pressure on the hospital services and in particular, on the Intensive Care Units (ICU). Describing the need for critical care as well as the chance of being discharged from hospital according to patient characteristics, is essential for a more efficient hospital management. The objective of this study is to describe the probabilities of admission to the ICU and the probabilities of hospital discharge among positive COVID-19 patients according to demographics and comorbidities recorded at hospital admission. METHODS: A prospective cohort study of all patients with COVID-19 found in the Electronic Medical Records of Jaber Al-Ahmad Al-Sabah Hospital in Kuwait was conducted. The study included 3995 individuals (symptomatic and asymptomatic) of all ages who tested positive from February 24th to May 27th, 2020, out of which 315 were treated in the ICU and 3619 were discharged including those who were transferred to a different healthcare unit without having previously entered the ICU. A competing risk analysis considering two events, namely, ICU admission and hospital discharge using flexible hazard models was performed to describe the association between event-specific probabilities and patient characteristics. RESULTS: Results showed that being male, increasing age and comorbidities such as chronic kidney disease (CKD), asthma or chronic obstructive pulmonary disease and weakened immune system increased the risk of ICU admission within 10 days of entering the hospital. CKD and weakened immune system decreased the probabilities of discharge in both females and males however, the age-related pattern differed by gender. Diabetes, which was the most prevalent comorbid condition, had only a moderate impact on both probabilities (18% overall) in contrast to CKD which had the largest effect, but presented only in 7% of those admitted to ICU and in 1% of those who got discharged. For instance, within 5 days a 50-year-old male had 19% (95% C.I.: [15,23]) probability of entering the ICU if he had none of these comorbidities, yet this risk jumped to 31% (95% C.I.: [20,46]) if he had also CKD, and to 27% in the presence of asthma/COPD (95% C.I.: [19,36]) or of weakened immune system (95% C.I.: [16,42]). CONCLUSIONS: This study provides useful insight in describing the probabilities of ICU admission and hospital discharge according to age, gender, and comorbidities among confirmed COVID-19 cases in Kuwait. A web-tool is also provided to allow the user to estimate these probabilities for any combination of these covariates. These probabilities enable deeper understanding of the hospital demand according to patient characteristics which is essential to hospital management and useful for developing a vaccination strategy.


Subject(s)
COVID-19 , Hospitalization , Patient Discharge , Female , Hospital Mortality , Hospitalization/statistics & numerical data , Hospitals , Humans , Intensive Care Units , Kuwait/epidemiology , Malaysia , Male , Middle Aged , Middle East , Patient Discharge/statistics & numerical data , Probability , Prospective Studies , Retrospective Studies , SARS-CoV-2
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