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1.
Lancet Respir Med ; 9(5): 487-497, 2021 05.
Article in English | MEDLINE | ID: covidwho-1537196

ABSTRACT

BACKGROUND: Lung transplantation is a life-saving treatment for patients with end-stage lung disease; however, it is infrequently considered for patients with acute respiratory distress syndrome (ARDS) attributable to infectious causes. We aimed to describe the course of disease and early post-transplantation outcomes in critically ill patients with COVID-19 who failed to show lung recovery despite optimal medical management and were deemed to be at imminent risk of dying due to pulmonary complications. METHODS: We established a multi-institutional case series that included the first consecutive transplants for severe COVID-19-associated ARDS known to us in the USA, Italy, Austria, and India. De-identified data from participating centres-including information relating to patient demographics and pre-COVID-19 characteristics, pretransplantation disease course, perioperative challenges, pathology of explanted lungs, and post-transplantation outcomes-were collected by Northwestern University (Chicago, IL, USA) and analysed. FINDINGS: Between May 1 and Sept 30, 2020, 12 patients with COVID-19-associated ARDS underwent bilateral lung transplantation at six high-volume transplant centres in the USA (eight recipients at three centres), Italy (two recipients at one centre), Austria (one recipient), and India (one recipient). The median age of recipients was 48 years (IQR 41-51); three of the 12 patients were female. Chest imaging before transplantation showed severe lung damage that did not improve despite prolonged mechanical ventilation and extracorporeal membrane oxygenation. The lung transplant procedure was technically challenging, with severe pleural adhesions, hilar lymphadenopathy, and increased intraoperative transfusion requirements. Pathology of the explanted lungs showed extensive, ongoing acute lung injury with features of lung fibrosis. There was no recurrence of SARS-CoV-2 in the allografts. All patients with COVID-19 could be weaned off extracorporeal support and showed short-term survival similar to that of transplant recipients without COVID-19. INTERPRETATION: The findings from our report show that lung transplantation is the only option for survival in some patients with severe, unresolving COVID-19-associated ARDS, and that the procedure can be done successfully, with good early post-transplantation outcomes, in carefully selected patients. FUNDING: National Institutes of Health. VIDEO ABSTRACT.


Subject(s)
COVID-19 , Critical Illness/therapy , Lung Transplantation/methods , Lung , Respiratory Distress Syndrome , Blood Transfusion/methods , COVID-19/complications , COVID-19/diagnosis , COVID-19/physiopathology , COVID-19/surgery , Critical Care/methods , Extracorporeal Membrane Oxygenation/methods , Female , Humans , Intraoperative Care/methods , Lung/diagnostic imaging , Lung/pathology , Male , Middle Aged , Outcome and Process Assessment, Health Care , Pulmonary Fibrosis/etiology , Pulmonary Fibrosis/pathology , Respiration, Artificial/methods , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/surgery , SARS-CoV-2/pathogenicity
2.
JAMA ; 326(17): 1690-1702, 2021 Nov 02.
Article in English | MEDLINE | ID: covidwho-1525402

ABSTRACT

Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. Objective: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. Design, Setting, and Participants: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. Interventions: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). Main Outcomes and Measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events. Results: Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group. Conclusions and Relevance: Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707.


Subject(s)
COVID-19/therapy , ABO Blood-Group System , Adult , Aged , Critical Illness/therapy , Female , Hospital Mortality , Humans , Immunization, Passive , Length of Stay , Logistic Models , Male , Middle Aged , Respiration, Artificial/statistics & numerical data , Treatment Failure , Vasoconstrictor Agents/therapeutic use
3.
Minerva Anestesiol ; 87(11): 1168-1170, 2021 11.
Article in English | MEDLINE | ID: covidwho-1518899
4.
Minerva Anestesiol ; 87(11): 1209-1216, 2021 11.
Article in English | MEDLINE | ID: covidwho-1518895

ABSTRACT

BACKGROUND: Our objective was to the describe indications, management, complications and outcomes of renal replacement therapy (RRT) in COVID-19 critically ill patients. To contextualize these findings, comparisons were made against 36 non-COVID-19 consecutive patients requiring RRT on ICU. METHODS: We conducted a retrospective single center observational cohort study of patients requiring acute RRT between 1st March and 30th June 2020. Comparison was made against those receiving RRT in the pre-COVID-19 period from January 2019 to February 2020. RESULTS: Of 154 COVID-19 patients, 47 (30.5%) received continuous venovenous hemofiltration (CVVHF), all of whom required mechanical ventilation and vasopressor support. The requirement for RRT was related to fluid balance rather than azotemia. Compared to 36 non-COVID-19 patients, those with COVID-19 were younger (P=0.016) with a lower serum creatinine on hospital admission (P=0.049), and lesser degrees of metabolic acidosis (P<0.001) and lactatemia (P<0.001) before initiation of RRT. In addition, the duration of RRT requirement was longer (P<0.001). Despite lower CVVHF exchange rates with higher serum creatinine levels following RRT initiation in the COVID-19 patients, metabolic abnormalities were corrected. Hospital mortality was 60% among COVID-19 patients requiring RRT, compared to 67% in non-COVID-19 patients (P=0.508), and renal recovery among survivors without pre-existing CKD was similar (P=0.231). CONCLUSIONS: The requirement for RRT in COVID-19 patients was primarily related to fluid balance. Using lower CVVHF exchange rates was effective to correct metabolic abnormalities. Renal recovery occurred in all but one patient by 60 days in the 40% of patients who survived.


Subject(s)
Acute Kidney Injury , COVID-19 , Acute Kidney Injury/epidemiology , Acute Kidney Injury/therapy , Critical Illness/therapy , Humans , Intensive Care Units , Pandemics , Renal Replacement Therapy , Retrospective Studies , SARS-CoV-2
5.
Anesthesiology ; 135(6): 1076-1090, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1507118

ABSTRACT

BACKGROUND: Mortality in critically ill COVID-19 patients remains high. Although randomized controlled trials must continue to definitively evaluate treatments, further hypothesis-generating efforts to identify candidate treatments are required. This study's hypothesis was that certain treatments are associated with lower COVID-19 mortality. METHODS: This was a 1-yr retrospective cohort study involving all COVID-19 patients admitted to intensive care units in six hospitals affiliated with Yale New Haven Health System from February 13, 2020, to March 4, 2021. The exposures were any COVID-19-related pharmacologic and organ support treatments. The outcome was in-hospital mortality. RESULTS: This study analyzed 2,070 patients after excluding 23 patients who died within 24 h after intensive care unit admission and 3 patients who remained hospitalized on the last day of data censoring. The in-hospital mortality was 29% (593 of 2,070). Of 23 treatments analyzed, apixaban (hazard ratio, 0.42; 95% CI, 0.363 to 0.48; corrected CI, 0.336 to 0.52) and aspirin (hazard ratio, 0.72; 95% CI, 0.60 to 0.87; corrected CI, 0.54 to 0.96) were associated with lower mortality based on the multivariable analysis with multiple testing correction. Propensity score-matching analysis showed an association between apixaban treatment and lower mortality (with vs. without apixaban, 27% [96 of 360] vs. 37% [133 of 360]; hazard ratio, 0.48; 95% CI, 0.337 to 0.69) and an association between aspirin treatment and lower mortality (with vs. without aspirin, 26% [121 of 473] vs. 30% [140 of 473]; hazard ratio, 0.57; 95% CI, 0.41 to 0.78). Enoxaparin showed similar associations based on the multivariable analysis (hazard ratio, 0.82; 95% CI, 0.69 to 0.97; corrected CI, 0.61 to 1.05) and propensity score-matching analysis (with vs. without enoxaparin, 25% [87 of 347] vs. 34% [117 of 347]; hazard ratio, 0.53; 95% CI, 0.367 to 0.77). CONCLUSIONS: Consistent with the known hypercoagulability in severe COVID-19, the use of apixaban, enoxaparin, or aspirin was independently associated with lower mortality in critically ill COVID-19 patients.


Subject(s)
COVID-19/drug therapy , COVID-19/mortality , Critical Illness/mortality , Critical Illness/therapy , Aged , Aged, 80 and over , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anticoagulants/administration & dosage , Antiviral Agents/administration & dosage , Cohort Studies , Factor Xa Inhibitors/administration & dosage , Female , Humans , Male , Middle Aged , Mortality/trends , Retrospective Studies , Treatment Outcome
6.
Crit Care ; 25(1): 382, 2021 11 08.
Article in English | MEDLINE | ID: covidwho-1506095

ABSTRACT

BACKGROUND: There are few reports of new functional impairment following critical illness from COVID-19. We aimed to describe the incidence of death or new disability, functional impairment and changes in health-related quality of life of patients after COVID-19 critical illness at 6 months. METHODS: In a nationally representative, multicenter, prospective cohort study of COVID-19 critical illness, we determined the prevalence of death or new disability at 6 months, the primary outcome. We measured mortality, new disability and return to work with changes in the World Health Organization Disability Assessment Schedule 2.0 12L (WHODAS) and health status with the EQ5D-5LTM. RESULTS: Of 274 eligible patients, 212 were enrolled from 30 hospitals. The median age was 61 (51-70) years, and 124 (58.5%) patients were male. At 6 months, 43/160 (26.9%) patients died and 42/108 (38.9%) responding survivors reported new disability. Compared to pre-illness, the WHODAS percentage score worsened (mean difference (MD), 10.40% [95% CI 7.06-13.77]; p < 0.001). Thirteen (11.4%) survivors had not returned to work due to poor health. There was a decrease in the EQ-5D-5LTM utility score (MD, - 0.19 [- 0.28 to - 0.10]; p < 0.001). At 6 months, 82 of 115 (71.3%) patients reported persistent symptoms. The independent predictors of death or new disability were higher severity of illness and increased frailty. CONCLUSIONS: At six months after COVID-19 critical illness, death and new disability was substantial. Over a third of survivors had new disability, which was widespread across all areas of functioning. Clinical trial registration NCT04401254 May 26, 2020.


Subject(s)
COVID-19/epidemiology , Critical Illness/epidemiology , Disabled Persons , Recovery of Function/physiology , Return to Work/trends , Aged , Aged, 80 and over , Australia/epidemiology , COVID-19/diagnosis , COVID-19/therapy , Cohort Studies , Critical Illness/therapy , Female , Follow-Up Studies , Health Status , Humans , Male , Middle Aged , Mortality/trends , Prospective Studies , Time Factors , Treatment Outcome
8.
Ther Drug Monit ; 43(4): 451-454, 2021 08 01.
Article in English | MEDLINE | ID: covidwho-1501177

ABSTRACT

OBJECTIVE: The authors report on a case of a 59-year-old man hospitalized in the intensive care unit because of severe SARS-COV-2 infection (COVID-19). BACKGROUND: The patient had several comorbidities, including liver cirrhosis. He developed ventilation-associated bacterial pneumonia for which he was administered cefepime at an initial dose of 2 g/8 hours. Therapeutic drug monitoring was performed, showing overexposure with an initial trough concentration of >60 mg/L. METHODS: Analysis of pharmacokinetic data and model-based dose adjustment was performed using BestDose software. RESULTS: The patient had unexpected pharmacokinetic parameter values. Serum creatinine was only moderately increased, whereas measured creatinine clearance based on urine collection showed impaired renal function. Bacterial minimum inhibitory concentration was also considered in the dosing decisions. After dose reduction to 0.5 g/8 hours, the cefepime trough concentration progressively declined and reached the target values by the end of the therapy. A post-hoc analysis provided a different interpretation of drug overexposure. CONCLUSION: This case report illustrates how physiological, microbiological, and drug concentration data can be used for model-based dosage individualization of cefepime in intensive care unit patients.


Subject(s)
Anti-Bacterial Agents/pharmacokinetics , Cefepime/pharmacokinetics , Critical Illness/therapy , Drug Dosage Calculations , Precision Medicine/methods , Acute Kidney Injury/blood , Acute Kidney Injury/chemically induced , Acute Kidney Injury/prevention & control , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/adverse effects , Cefepime/administration & dosage , Cefepime/adverse effects , Humans , Male , Middle Aged
9.
Crit Care ; 25(1): 363, 2021 10 18.
Article in English | MEDLINE | ID: covidwho-1477449

ABSTRACT

BACKGROUND: Zinc is a trace element that plays a role in stimulating innate and acquired immunity. The role of zinc in critically ill patients with COVID-19 remains unclear. This study aims to evaluate the efficacy and safety of zinc sulfate as adjunctive therapy in critically ill patients with COVID-19. METHODS: Patients aged ≥ 18 years with COVID-19 who were admitted to the intensive care unit (ICU) in two tertiary hospitals in Saudi Arabia were retrospectively assessed for zinc use from March 1, 2020 until March 31, 2021. After propensity score matching (1:1 ratio) based on the selected criteria, we assessed the association of zinc used as adjunctive therapy with the 30-day mortality. Secondary outcomes included the in-hospital mortality, ventilator free days, ICU length of stay (LOS), hospital LOS, and complication (s) during ICU stay. RESULTS: A total of 164 patients were included, 82 patients received zinc. Patients who received zinc sulfate as adjunctive therapy have a lower 30-day mortality (HR 0.52, CI 0.29, 0.92; p = 0.03). On the other hand, the in-hospital mortality was not statistically significant between the two groups (HR 0.64, CI 0.37-1.10; p = 0.11). Zinc sulfate use was associated with a lower odds of acute kidney injury development during ICU stay (OR 0.46 CI 0.19-1.06; p = 0.07); however, it did not reach statistical significance. CONCLUSION: The use of zinc sulfate as an additional treatment in critically ill COVID-19 patients may improve survival. Furthermore, zinc supplementation may have a protective effect on the kidneys.


Subject(s)
COVID-19/drug therapy , COVID-19/mortality , Critical Illness/therapy , Neoadjuvant Therapy/methods , Zinc Sulfate/therapeutic use , Aged , Female , Humans , Male , Middle Aged , Propensity Score , Retrospective Studies , Saudi Arabia , Survival Rate
10.
Crit Care Med ; 49(10): e1037-e1039, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1475866

ABSTRACT

OBJECTIVES: To determine if a restrictive visitor policy inadvertently lengthened the decision-making process for dying inpatients without coronavirus disease 2019. DESIGN: Regression discontinuity and time-to-event analysis. SETTING: Two large academic hospitals in a unified health system. PATIENTS OR SUBJECTS: Adult decedents who received greater than or equal to 1 day of ICU care during their terminal admission over a 12-month period. INTERVENTIONS: Implementation of a visit restriction policy. MEASUREMENTS AND MAIN RESULTS: We identified 940 adult decedents without coronavirus disease 2019 during the study period. For these patients, ICU length of stay was 0.8 days longer following policy implementation, although this effect was not statistically significant (95% CI, -2.3 to 3.8; p = 0.63). After excluding patients admitted before the policy but who died after implementation, we observed that ICU length of stay was 2.9 days longer post-policy (95% CI, 0.27-5.6; p = 0.03). A time-to-event analysis revealed that admission after policy implementation was associated with a significantly longer time to first do not resuscitate/do not intubate/comfort care order (adjusted hazard ratio, 2.2; 95% CI, 1.6-3.1; p < 0.0001). CONCLUSIONS: Policies restricting family presence may lead to longer ICU stays and delay decisions to limit treatment prior to death. Further policy evaluation and programs enabling access to family-centered care and palliative care during the ongoing coronavirus disease 2019 pandemic are imperative.


Subject(s)
COVID-19/mortality , Decision Making , Health Policy , Visitors to Patients/statistics & numerical data , Adult , Aged , COVID-19/complications , COVID-19/psychology , Critical Illness/mortality , Critical Illness/therapy , Female , Humans , Male , Middle Aged , Terminal Care/methods , Terminal Care/psychology , Terminal Care/standards
11.
Anaesthesist ; 70(7): 573-581, 2021 07.
Article in German | MEDLINE | ID: covidwho-1453676

ABSTRACT

BACKGROUND: In a pandemic situation the overall mortality rate is of considerable interest; however, these data must always be seen in relation to the given healthcare system and the availability of local level of care. A recently published German data evaluation of more than 10,000 COVID-19 patients treated in 920 hospitals showed a high mortality rate of 22% in hospitalized patients and of more than 50% in patients requiring invasive ventilation. Because of the high infection rates in Bavaria, a large number of COVID-19 patients with considerable severity of disease were treated at the intensive care units of the LMU hospital. The LMU hospital is a university hospital and a specialized referral center for the treatment of patients with acute respiratory distress syndrome (ARDS). OBJECTIVE: Data of LMU intensive care unit (ICU) patients were systematically evaluated and compared with the recently published German data. METHODS: Data of all COVID-19 patients with invasive and noninvasive ventilation and with completed admission at the ICU of the LMU hospital until 31 July 2020 were collected. Data were processed using descriptive statistics. RESULTS: In total 70 critically ill patients were included in the data evaluation. The median SAPS II on admission to the ICU was 62 points. The median age was 66 years and 81% of the patients were male. More than 90% were diagnosed with ARDS and received invasive ventilation. Treatment with extracorporeal membrane oxygenation (ECMO) was necessary in 10% of the patients. The median duration of ventilation was 16 days, whereby 34.3% of patients required a tracheostomy. Of the patients 27.1% were transferred to the LMU hospital from external hospitals with reference to our ARDS/ECMO program. Patients from external hospitals had ARDS of higher severity than the total study population. In total, nine different substances were used for virus-specific treatment of COVID-19. The most frequently used substances were hydroxychloroquine and azithromycin. Immunomodulatory treatment, such as Cytosorb® (18.6%) and methylprednisolone (25.7%) were also frequently used. The overall in-hospital mortality rate of ICU patients requiring ventilation was 28.6%. The mortality rates of patients from external hospitals, patients with renal replacement therapy and patients with ECMO therapy were 47.4%, 56.7% and 85.7%, respectively. CONCLUSION: The mortality rate in the ventilated COVID-19 intensive care patients was considerably different from the general rate in Germany. The data showed that treatment in an ARDS referral center could result in a lower mortality rate. Low-dose administration of steroids may be another factor to improve patient outcome in a preselected patient population. In the authors' opinion, critically ill COVID-19 patients should be treated in an ARDS center provided that sufficient resources are available.


Subject(s)
COVID-19/therapy , Respiration, Artificial/statistics & numerical data , Aged , Aged, 80 and over , Antiviral Agents/therapeutic use , COVID-19/complications , COVID-19/mortality , Critical Illness/therapy , Extracorporeal Membrane Oxygenation , Female , Germany , Hospital Mortality , Hospitals, University , Humans , Immunologic Factors/therapeutic use , Intensive Care Units/statistics & numerical data , Male , Middle Aged , Patient Transfer , Renal Replacement Therapy/statistics & numerical data , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Treatment Outcome
12.
JAMA ; 323(16): 1574-1581, 2020 04 28.
Article in English | MEDLINE | ID: covidwho-1453471

ABSTRACT

Importance: In December 2019, a novel coronavirus (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) emerged in China and has spread globally, creating a pandemic. Information about the clinical characteristics of infected patients who require intensive care is limited. Objective: To characterize patients with coronavirus disease 2019 (COVID-19) requiring treatment in an intensive care unit (ICU) in the Lombardy region of Italy. Design, Setting, and Participants: Retrospective case series of 1591 consecutive patients with laboratory-confirmed COVID-19 referred for ICU admission to the coordinator center (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy) of the COVID-19 Lombardy ICU Network and treated at one of the ICUs of the 72 hospitals in this network between February 20 and March 18, 2020. Date of final follow-up was March 25, 2020. Exposures: SARS-CoV-2 infection confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasal and pharyngeal swabs. Main Outcomes and Measures: Demographic and clinical data were collected, including data on clinical management, respiratory failure, and patient mortality. Data were recorded by the coordinator center on an electronic worksheet during telephone calls by the staff of the COVID-19 Lombardy ICU Network. Results: Of the 1591 patients included in the study, the median (IQR) age was 63 (56-70) years and 1304 (82%) were male. Of the 1043 patients with available data, 709 (68%) had at least 1 comorbidity and 509 (49%) had hypertension. Among 1300 patients with available respiratory support data, 1287 (99% [95% CI, 98%-99%]) needed respiratory support, including 1150 (88% [95% CI, 87%-90%]) who received mechanical ventilation and 137 (11% [95% CI, 9%-12%]) who received noninvasive ventilation. The median positive end-expiratory pressure (PEEP) was 14 (IQR, 12-16) cm H2O, and Fio2 was greater than 50% in 89% of patients. The median Pao2/Fio2 was 160 (IQR, 114-220). The median PEEP level was not different between younger patients (n = 503 aged ≤63 years) and older patients (n = 514 aged ≥64 years) (14 [IQR, 12-15] vs 14 [IQR, 12-16] cm H2O, respectively; median difference, 0 [95% CI, 0-0]; P = .94). Median Fio2 was lower in younger patients: 60% (IQR, 50%-80%) vs 70% (IQR, 50%-80%) (median difference, -10% [95% CI, -14% to 6%]; P = .006), and median Pao2/Fio2 was higher in younger patients: 163.5 (IQR, 120-230) vs 156 (IQR, 110-205) (median difference, 7 [95% CI, -8 to 22]; P = .02). Patients with hypertension (n = 509) were older than those without hypertension (n = 526) (median [IQR] age, 66 years [60-72] vs 62 years [54-68]; P < .001) and had lower Pao2/Fio2 (median [IQR], 146 [105-214] vs 173 [120-222]; median difference, -27 [95% CI, -42 to -12]; P = .005). Among the 1581 patients with ICU disposition data available as of March 25, 2020, 920 patients (58% [95% CI, 56%-61%]) were still in the ICU, 256 (16% [95% CI, 14%-18%]) were discharged from the ICU, and 405 (26% [95% CI, 23%-28%]) had died in the ICU. Older patients (n = 786; age ≥64 years) had higher mortality than younger patients (n = 795; age ≤63 years) (36% vs 15%; difference, 21% [95% CI, 17%-26%]; P < .001). Conclusions and Relevance: In this case series of critically ill patients with laboratory-confirmed COVID-19 admitted to ICUs in Lombardy, Italy, the majority were older men, a large proportion required mechanical ventilation and high levels of PEEP, and ICU mortality was 26%.


Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Critical Care/statistics & numerical data , Hospital Mortality , Intensive Care Units/statistics & numerical data , Pneumonia, Viral/epidemiology , Positive-Pressure Respiration/statistics & numerical data , Adolescent , Adult , Age Distribution , Aged , Aged, 80 and over , COVID-19 , Comorbidity , Coronavirus Infections/mortality , Coronavirus Infections/physiopathology , Coronavirus Infections/therapy , Critical Illness/therapy , Female , Hospitalization , Humans , Italy/epidemiology , Male , Middle Aged , Pandemics , Pneumonia, Viral/mortality , Pneumonia, Viral/physiopathology , Pneumonia, Viral/therapy , Respiration, Artificial , Retrospective Studies , SARS-CoV-2 , Sex Distribution , Young Adult
13.
Crit Care ; 25(1): 283, 2021 08 06.
Article in English | MEDLINE | ID: covidwho-1398871

ABSTRACT

BACKGROUND: The intensity of ventilation, reflected by driving pressure (ΔP) and mechanical power (MP), has an association with outcome in invasively ventilated patients with or without acute respiratory distress syndrome (ARDS). It is uncertain if a similar association exists in coronavirus disease 2019 (COVID-19) patients with acute respiratory failure. METHODS: We aimed to investigate the impact of intensity of ventilation on patient outcome. The PRoVENT-COVID study is a national multicenter observational study in COVID-19 patients receiving invasive ventilation. Ventilator parameters were collected a fixed time points on the first calendar day of invasive ventilation. Mean dynamic ΔP and MP were calculated for individual patients at time points without evidence of spontaneous breathing. A Cox proportional hazard model, and a double stratification analysis adjusted for confounders were used to estimate the independent associations of ΔP and MP with outcome. The primary endpoint was 28-day mortality. RESULTS: In 825 patients included in this analysis, 28-day mortality was 27.5%. ΔP was not independently associated with mortality (HR 1.02 [95% confidence interval 0.88-1.18]; P = 0.750). MP, however, was independently associated with 28-day mortality (HR 1.17 [95% CI 1.01-1.36]; P = 0.031), and increasing quartiles of MP, stratified on comparable levels of ΔP, had higher risks of 28-day mortality (HR 1.15 [95% CI 1.01-1.30]; P = 0.028). CONCLUSIONS: In this cohort of critically ill invasively ventilated COVID-19 patients with acute respiratory failure, we show an independent association of MP, but not ΔP with 28-day mortality. MP could serve as one prognostic biomarker in addition to ΔP in these patients. Efforts aiming at limiting both ΔP and MP could translate in a better outcome. Trial registration Clinicaltrials.gov (study identifier NCT04346342).


Subject(s)
COVID-19/mortality , COVID-19/therapy , Respiration, Artificial/mortality , Respiratory Distress Syndrome/mortality , Respiratory Distress Syndrome/therapy , Aged , Cohort Studies , Critical Illness/mortality , Critical Illness/therapy , Female , Humans , Male , Middle Aged , Mortality/trends , Respiration, Artificial/trends , Retrospective Studies , Tidal Volume/physiology
14.
Palliat Med ; 35(8): 1519-1524, 2021 09.
Article in English | MEDLINE | ID: covidwho-1390431

ABSTRACT

BACKGROUND: Early in the Covid-19 pandemic, there was uncertainty regarding critical illness prognosis and challenges to traditional face-to-face family meetings. Ethnic minority populations have suffered disproportionately worse outcomes during the pandemic, which may in part relate to differences in end-of-life decision-making. AIM: Characterize patterns of and factors associated with decisions to forgo resuscitative efforts, as measured by do-not-resuscitate orders, during critical illness with Covid-19. DESIGN: Retrospective cohort with medical record abstraction. SETTING/PARTICIPANTS: Adult patients diagnosed with SARS-Cov-2 virus via polymerase chain reaction and admitted to the intensive care unit at an academic hospital, which cares for the city's underserved communities, between March 1 and June 7, 2020 who underwent invasive mechanical ventilation for at least 48 hours. RESULTS: In this cohort (n = 155), 45% were black people, and 51% spoke English as their primary language. Median time to first goals-of-care conversation was 3.9 days (IQR 1.9-7.6) after intensive care unit admission. Overall 61/155 patients (39%) transitioned to do-not-resuscitate status, and 50/62 (82%) patients who died had do-not-resuscitate orders. Multivariate analysis shows age and palliative care involvement as the strongest predictors of decision to instate do-not-resuscitate order. There was no association between race, ethnicity, or language and decisions to forego resuscitation. CONCLUSIONS: During this time of crisis and uncertainty with limited resources and strained communication, time to first goals of care conversation was shorter than in pre-pandemic studies, but rates of foregoing resuscitation remained similar, with no differences observed by race, ethnicity, or language. This study suggests that early palliative care involvement and non-traditional communications, including videoconferencing, to facilitate goals of care conversations could have mitigated potential disparities in end-of-life decision making patterns during the pandemic.


Subject(s)
COVID-19 , Pandemics , Adult , Critical Illness/therapy , Ethnic Groups , Humans , Intensive Care Units , Minority Groups , Resuscitation Orders , Retrospective Studies , SARS-CoV-2
17.
Nutr Clin Pract ; 36(5): 984-992, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1380401

ABSTRACT

BACKGROUND: Recent studies indicate critically ill patients with coronavirus disease 2019 (COVID-19) are hypermetabolic; however, protein requirements in critically ill COVID-19 patients are unknown. Our intent was to evaluate the nitrogen accretion response to varying protein intakes for critically ill ventilator-dependent patients with COVID-19. METHODS: Adult patients (age ≥ 18 years) with COVID-19, admitted to the intensive care unit (ICU) and who required mechanical ventilation were retrospectively evaluated. Patients received continuous enteral nutrition (EN), including supplemental protein boluses, and had a 24-h urine collection for determination of nitrogen balance (NBAL). Data are expressed as mean ± SD with a P-value < .05 as significant. RESULTS: Twenty-two patients provided 29 NBAL determinations. Protein intake from EN and protein supplements was 0.9 ± 0.7 g/kg/day at the time of the NBAL with an NBAL of -12.1 ± 10.9 g/day at 7 ± 4 days in the ICU. Combined caloric intake from EN and propofol at the time of the NBAL was 12 ± 8 kcal/kg/day. Nitrogen equilibrium (NBAL of -4 g/day or better) occurred in five patients. Patients achieving nitrogen equilibrium received more protein than those with a negative NBAL (1.2 ± 0.4 g/kg/day vs 0.8 ± 0.8 g/kg/day, P = .046). The linear regression for NBAL in response to graded increases in protein intake was as follows: NBAL = 8.5 × protein intake (g/kg/day) - 18.8 (r = 0.450, P < .001). CONCLUSION: Critically ill ventilator-dependent patients with COVID-19 exhibit significant variability in nitrogen accretion response to increases in protein intake and often have a markedly negative NBAL.


Subject(s)
COVID-19 , Critical Illness , Adolescent , Adult , Critical Illness/therapy , Energy Intake , Humans , Intensive Care Units , Nutritional Requirements , Retrospective Studies , SARS-CoV-2 , Ventilators, Mechanical
18.
BMJ Open ; 11(8): e050881, 2021 08 25.
Article in English | MEDLINE | ID: covidwho-1373968

ABSTRACT

INTRODUCTION: Critical care is essential in saving lives of those that are critically ill, however, provision of critical care can be costly and heterogeneous across lower-resource settings. This paper describes the protocol for a systematic review of the literature that aims to identify the reported costs and resources available for the provision of critical care and the forms of critical care provision in Tanzania. METHODS AND ANALYSIS: The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Three databases (MEDLINE, Embase and Global Health) will be searched to identify articles that report the forms of critical care, resources used in the provision of critical care in Tanzania, their availability and the associated costs. The search strategy will be developed from four key concepts; critical care provision, critical illness, resource use, Tanzania. The articles that fulfil the inclusion and exclusion criteria will be assessed for quality using the Reference Case for Estimating the Costs of Global Health Services and Interventions checklist. The extracted data will be summarised using descriptive statistics including frequencies, mean and median of the quantity and costs of resources used in the components of critical care services, depending on the data availability. This study will be carried out between February and November 2021. ETHICS AND DISSEMINATION: This study is a review of secondary data and ethical clearance was sought from and granted by the Tanzanian National Institute of Medical Research (reference: NIMR/HQ/R.8a/Vol. IX/3537) and London School of Hygiene and Tropical Medicine (ethics ref: 22866). We will publish the review in a peer-reviewed journal as an open access article in addition to presenting the findings at conferences and public scientific gatherings. PROSPERO REGISTRATION NUMBER: The protocol was registered with PROSPERO; registration number: CRD42020221923.


Subject(s)
Critical Care , Research Design , Critical Illness/therapy , Humans , London , Review Literature as Topic , Tanzania
19.
J Am Coll Cardiol ; 78(10): 1001-1011, 2021 09 07.
Article in English | MEDLINE | ID: covidwho-1371478

ABSTRACT

BACKGROUND: Severe coronavirus disease-2019 (COVID-19) can progress to an acute respiratory distress syndrome (ARDS), which involves alveolar infiltration by activated neutrophils. The beta-blocker metoprolol has been shown to ameliorate exacerbated inflammation in the myocardial infarction setting. OBJECTIVES: The purpose of this study was to evaluate the effects of metoprolol on alveolar inflammation and on respiratory function in patients with COVID-19-associated ARDS. METHODS: A total of 20 COVID-19 patients with ARDS on invasive mechanical ventilation were randomized to metoprolol (15 mg daily for 3 days) or control (no treatment). All patients underwent bronchoalveolar lavage (BAL) before and after metoprolol/control. The safety of metoprolol administration was evaluated by invasive hemodynamic and electrocardiogram monitoring and echocardiography. RESULTS: Metoprolol administration was without side effects. At baseline, neutrophil content in BAL did not differ between groups. Conversely, patients randomized to metoprolol had significantly fewer neutrophils in BAL on day 4 (median: 14.3 neutrophils/µl [Q1, Q3: 4.63, 265 neutrophils/µl] vs median: 397 neutrophils/µl [Q1, Q3: 222, 1,346 neutrophils/µl] in the metoprolol and control groups, respectively; P = 0.016). Metoprolol also reduced neutrophil extracellular traps content and other markers of lung inflammation. Oxygenation (PaO2:FiO2) significantly improved after 3 days of metoprolol treatment (median: 130 [Q1, Q3: 110, 162] vs median: 267 [Q1, Q3: 199, 298] at baseline and day 4, respectively; P = 0.003), whereas it remained unchanged in control subjects. Metoprolol-treated patients spent fewer days on invasive mechanical ventilation than those in the control group (15.5 ± 7.6 vs 21.9 ± 12.6 days; P = 0.17). CONCLUSIONS: In this pilot trial, intravenous metoprolol administration to patients with COVID-19-associated ARDS was safe, reduced exacerbated lung inflammation, and improved oxygenation. Repurposing metoprolol for COVID-19-associated ARDS appears to be a safe and inexpensive strategy that can alleviate the burden of the COVID-19 pandemic.


Subject(s)
COVID-19/transmission , Critical Illness/therapy , Metoprolol/administration & dosage , Pandemics , Respiration, Artificial/methods , SARS-CoV-2 , Adrenergic beta-1 Receptor Antagonists/administration & dosage , Adult , Aged , COVID-19/epidemiology , Female , Humans , Injections, Intravenous , Male , Middle Aged , Pilot Projects , Prospective Studies
20.
Crit Care ; 25(1): 295, 2021 Aug 17.
Article in English | MEDLINE | ID: covidwho-1362062

ABSTRACT

BACKGROUND: Intensive Care Resources are heavily utilized during the COVID-19 pandemic. However, risk stratification and prediction of SARS-CoV-2 patient clinical outcomes upon ICU admission remain inadequate. This study aimed to develop a machine learning model, based on retrospective & prospective clinical data, to stratify patient risk and predict ICU survival and outcomes. METHODS: A Germany-wide electronic registry was established to pseudonymously collect admission, therapeutic and discharge information of SARS-CoV-2 ICU patients retrospectively and prospectively. Machine learning approaches were evaluated for the accuracy and interpretability of predictions. The Explainable Boosting Machine approach was selected as the most suitable method. Individual, non-linear shape functions for predictive parameters and parameter interactions are reported. RESULTS: 1039 patients were included in the Explainable Boosting Machine model, 596 patients retrospectively collected, and 443 patients prospectively collected. The model for prediction of general ICU outcome was shown to be more reliable to predict "survival". Age, inflammatory and thrombotic activity, and severity of ARDS at ICU admission were shown to be predictive of ICU survival. Patients' age, pulmonary dysfunction and transfer from an external institution were predictors for ECMO therapy. The interaction of patient age with D-dimer levels on admission and creatinine levels with SOFA score without GCS were predictors for renal replacement therapy. CONCLUSIONS: Using Explainable Boosting Machine analysis, we confirmed and weighed previously reported and identified novel predictors for outcome in critically ill COVID-19 patients. Using this strategy, predictive modeling of COVID-19 ICU patient outcomes can be performed overcoming the limitations of linear regression models. Trial registration "ClinicalTrials" (clinicaltrials.gov) under NCT04455451.


Subject(s)
COVID-19/epidemiology , Critical Illness/epidemiology , Electronic Health Records/statistics & numerical data , Intensive Care Units , Machine Learning , Adult , Aged , COVID-19/therapy , Cohort Studies , Critical Illness/therapy , Emergency Service, Hospital , Female , Germany , Humans , Male , Middle Aged , Outcome Assessment, Health Care
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