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1.
Acta Anaesthesiol Scand ; 67(5): 569-575, 2023 05.
Article in English | MEDLINE | ID: covidwho-2213441

ABSTRACT

This rapid practice guideline provides evidence-based recommendations for the use of awake proning in adult patients with acute hypoxemic respiratory failure due to COVID-19. The panel included 20 experts from 12 countries, including one patient representative, and used a strict conflict of interest policy for potential financial and intellectual conflicts of interest. Methodological support was provided by the guidelines in intensive care, development, and evaluation (GUIDE) group. Based on an updated systematic review, and the grading of recommendations, assessment, development, and evaluation (GRADE) method we evaluated the certainty of evidence and developed recommendations using the Evidence-to-Decision framework. We conducted an electronic vote, requiring >80% agreement amongst the panel for a recommendation to be adopted. The panel made a strong recommendation for a trial of awake proning in adult patients with COVID-19 related hypoxemic acute respiratory failure who are not invasively ventilated. Awake proning appears to reduce the risk of tracheal intubation, although it may not reduce mortality. The panel judged that most patients would want a trial of awake proning, although this may not be feasible in some patients and some patients may not tolerate it. However, given the high risk of clinical deterioration amongst these patients, awake proning should be conducted in an area where patients can be monitored by staff experienced in rapidly detecting and managing clinical deterioration. This RPG panel recommends a trial of awake prone positioning in patients with acute hypoxemic respiratory failure due to COVID-19.


Subject(s)
COVID-19 , Clinical Deterioration , Respiratory Insufficiency , Adult , Humans , COVID-19/complications , COVID-19/therapy , Prone Position , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy , SARS-CoV-2 , Wakefulness
2.
Int J Nephrol ; 2022: 9088393, 2022.
Article in English | MEDLINE | ID: covidwho-1950456

ABSTRACT

Data comparing the clinical spectrum of COVID-19 in kidney transplant recipients (KTRs) during the first and second waves of the pandemic in India is limited. Our single-center retrospective study compared the clinical profile, mortality, and associated risk factors in KTRs with COVID-19 during the 1st wave (1st February 2020 to 31st January 2021) and the second wave (1st March-31st August 2021). 156 KTRs with PCR confirmed SARS-CoV-2 infection treated at a tertiary care hospital in New Delhi during the 1st and the second waves were analyzed. The demographics and baseline transplant characteristics of the patients diagnosed during both waves were comparable. Patients in the second wave reported less frequent hospitalization, though the intensive care unit (ICU) and ventilator requirements were similar. Strategies to modify immunosuppressants such as discontinuation of antinucleoside drugs with or without change in calcineurin inhibitors and the use of steroids were similar during both waves. Overall patient mortality was 27.5%. The demographics and baseline characteristics of survivors and nonsurvivors were comparable. A higher percentage of nonsurvivors presented with breathing difficulty, low SpO2, and altered sensorium. Both wave risk factors for mortality included older age, severe disease, ICU/ventilator requirements, acute kidney injury (AKI) needing dialysis, Chest Computerized Tomographic (CT) scan abnormalities, and higher levels of inflammatory markers particularly D-dimer and interleukin-6 levels. Conclusions. KTRs in both COVID-19 waves had similar demographics and baseline characteristics, while fewer patients during the second wave required hospitalization. The D-dimer and IL-6 levels are directly correlated with mortality.

3.
Indian J Tuberc ; 69 Suppl 1: S1-S191, 2022.
Article in English | MEDLINE | ID: covidwho-1926544

ABSTRACT

Inhalational therapy, today, happens to be the mainstay of treatment in obstructive airway diseases (OADs), such as asthma, chronic obstructive pulmonary disease (COPD), and is also in the present, used in a variety of other pulmonary and even non-pulmonary disorders. Hand-held inhalation devices may often be difficult to use, particularly for children, elderly, debilitated or distressed patients. Nebulization therapy emerges as a good option in these cases besides being useful in the home care, emergency room and critical care settings. With so many advancements taking place in nebulizer technology; availability of a plethora of drug formulations for its use, and the widening scope of this therapy; medical practitioners, respiratory therapists, and other health care personnel face the challenge of choosing appropriate inhalation devices and drug formulations, besides their rational application and use in different clinical situations. Adequate maintenance of nebulizer equipment including their disinfection and storage are the other relevant issues requiring guidance. Injudicious and improper use of nebulizers and their poor maintenance can sometimes lead to serious health hazards, nosocomial infections, transmission of infection, and other adverse outcomes. Thus, it is imperative to have a proper national guideline on nebulization practices to bridge the knowledge gaps amongst various health care personnel involved in this practice. It will also serve as an educational and scientific resource for healthcare professionals, as well as promote future research by identifying neglected and ignored areas in this field. Such comprehensive guidelines on this subject have not been available in the country and the only available proper international guidelines were released in 1997 which have not been updated for a noticeably long period of over two decades, though many changes and advancements have taken place in this technology in the recent past. Much of nebulization practices in the present may not be evidence-based and even some of these, the way they are currently used, may be ineffective or even harmful. Recognizing the knowledge deficit and paucity of guidelines on the usage of nebulizers in various settings such as inpatient, out-patient, emergency room, critical care, and domiciliary use in India in a wide variety of indications to standardize nebulization practices and to address many other related issues; National College of Chest Physicians (India), commissioned a National task force consisting of eminent experts in the field of Pulmonary Medicine from different backgrounds and different parts of the country to review the available evidence from the medical literature on the scientific principles and clinical practices of nebulization therapy and to formulate evidence-based guidelines on it. The guideline is based on all possible literature that could be explored with the best available evidence and incorporating expert opinions. To support the guideline with high-quality evidence, a systematic search of the electronic databases was performed to identify the relevant studies, position papers, consensus reports, and recommendations published. Rating of the level of the quality of evidence and the strength of recommendation was done using the GRADE system. Six topics were identified, each given to one group of experts comprising of advisors, chairpersons, convenor and members, and such six groups (A-F) were formed and the consensus recommendations of each group was included as a section in the guidelines (Sections I to VI). The topics included were: A. Introduction, basic principles and technical aspects of nebulization, types of equipment, their choice, use, and maintenance B. Nebulization therapy in obstructive airway diseases C. Nebulization therapy in the intensive care unit D. Use of various drugs (other than bronchodilators and inhaled corticosteroids) by nebulized route and miscellaneous uses of nebulization therapy E. Domiciliary/Home/Maintenance nebulization therapy; public & health care workers education, and F. Nebulization therapy in COVID-19 pandemic and in patients of other contagious viral respiratory infections (included later considering the crisis created due to COVID-19 pandemic). Various issues in different sections have been discussed in the form of questions, followed by point-wise evidence statements based on the existing knowledge, and recommendations have been formulated.


Subject(s)
COVID-19 , Pulmonary Disease, Chronic Obstructive , Child , Humans , Aged , Pandemics , Bronchodilator Agents/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Health Personnel
4.
Transfus Apher Sci ; 61(6): 103497, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1915044

ABSTRACT

INTRODUCTION: Various therapies have been tried for Covid disease including the use of antivirals, steroids, monoclonal antibodies and convalescent plasma. METHOD: The study was conducted on convalescent plasma transfused ICU patients. Part A of the study involves clinical outcomes based on gender, age, comorbidities, blood group,and the average length of stay. Part B investigates clinical outcomes in patients transfused with convalescent plasma before and after the November 2021 guidelines. Part C of the study includes patients in cytokine storm and the efficacy of tocilizumab in these patients. RESULT: Out of the 326 ICU patients transfused with convalescent plasma the overall mortality was 152 (53.3 %). On comparing blood groups and clinical outcomes, a clinically significant result was found. A clinically significant association was also seen on comparing the clinical outcome of 18-50 years and 61-70 years age group and in female gender patients. The average number of ICU days had a positive impact on the overall patient survival. Out of the patients in 'cytokine storm' (n = 109), on day 20, the survival percentage in the non-Tocilizumab group showed a downward trend throughout. However, in the Tocilizumab group, the survival percentage remained stable throughout till around day 50. CONCLUSION: Amongst the convalescent plasma transfused ICU patients, females, having blood group B, and an average length of stay of fewer than 20 days had a better chance of survival. The patients given tocilizumab and convalescent plasma had a better chance of survival compared to tocilizumab alone.


Subject(s)
Blood Group Antigens , COVID-19 , Humans , Female , COVID-19/therapy , SARS-CoV-2 , Cytokine Release Syndrome , Immunization, Passive/adverse effects , Treatment Outcome , Cytokines , Intensive Care Units , COVID-19 Serotherapy
5.
Intensive Care Med ; 48(1): 45-55, 2022 01.
Article in English | MEDLINE | ID: covidwho-1605102

ABSTRACT

PURPOSE: We compared dexamethasone 12 versus 6 mg daily for up to 10 days in patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia in the international, randomised, blinded COVID STEROID 2 trial. In the primary, conventional analyses, the predefined statistical significance thresholds were not reached. We conducted a pre-planned Bayesian analysis to facilitate probabilistic interpretation. METHODS: We analysed outcome data within 90 days in the intention-to-treat population (data available in 967 to 982 patients) using Bayesian models with various sensitivity analyses. Results are presented as median posterior probabilities with 95% credible intervals (CrIs) and probabilities of different effect sizes with 12 mg dexamethasone. RESULTS: The adjusted mean difference on days alive without life support at day 28 (primary outcome) was 1.3 days (95% CrI -0.3 to 2.9; 94.2% probability of benefit). Adjusted relative risks and probabilities of benefit on serious adverse reactions was 0.85 (0.63 to 1.16; 84.1%) and on mortality 0.87 (0.73 to 1.03; 94.8%) at day 28 and 0.88 (0.75 to 1.02; 95.1%) at day 90. Probabilities of benefit on days alive without life support and days alive out of hospital at day 90 were 85 and 95.7%, respectively. Results were largely consistent across sensitivity analyses, with relatively low probabilities of clinically important harm with 12 mg on all outcomes in all analyses. CONCLUSION: We found high probabilities of benefit and low probabilities of clinically important harm with dexamethasone 12 mg versus 6 mg daily in patients with COVID-19 and severe hypoxaemia on all outcomes up to 90 days.


Subject(s)
COVID-19 Drug Treatment , Bayes Theorem , Dexamethasone , Humans , Hypoxia , SARS-CoV-2 , Steroids
6.
Lancet Respir Med ; 9(5): 511-521, 2021 05.
Article in English | MEDLINE | ID: covidwho-1537197

ABSTRACT

BACKGROUND: Global randomised controlled trials of the anti-IL-6 receptor antibody tocilizumab in patients admitted to hospital with COVID-19 have shown conflicting results but potential decreases in time to discharge and burden on intensive care. Tocilizumab reduced progression to mechanical ventilation and death in a trial population enriched for racial and ethnic minorities. We aimed to investigate whether tocilizumab treatment could prevent COVID-19 progression in the first multicentre randomised controlled trial of tocilizumab done entirely in a lower-middle-income country. METHODS: COVINTOC is an open-label, multicentre, randomised, controlled, phase 3 trial done at 12 public and private hospitals across India. Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result were randomly assigned (1:1 block randomisation) to receive tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone (the standard care group). The primary endpoint was progression of COVID-19 (from moderate to severe or from severe to death) up to day 14 in the modified intention-to-treat population of all participants who had at least one post-baseline assessment for the primary endpoint. Safety was assessed in all randomly assigned patients. The trial is completed and registered with the Clinical Trials Registry India (CTRI/2020/05/025369). FINDINGS: 180 patients were recruited between May 30, 2020, and Aug 31, 2020, and randomly assigned to the tocilizumab group (n=90) or the standard care group (n=90). One patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses. One patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses. 75 (82%) of 91 in the tocilizumab group and 68 (76%) of 89 in the standard care group completed 28 days of follow-up. Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3·71 [95% CI -18·23 to 11·19]; p=0·42). 33 (36%) of 91 patients in the tocilizumab group and 22 (25%) of 89 patients in the standard care group had adverse events; 18 (20%) and 15 (17%) had serious adverse events. The most common adverse event was acute respiratory distress syndrome, reported in seven (8%) patients in each group. Grade 3 adverse events were reported in two (2%) patients in the tocilizumab group and five (6%) patients in the standard care group. There were no grade 4 adverse events. Serious adverse events were reported in 18 (20%) patients in the tocilizumab group and 15 (17%) in the standard care group; 13 (14%) and 15 (17%) patients died during the study. INTERPRETATION: Routine use of tocilizumab in patients admitted to hospital with moderate to severe COVID-19 is not supported. However, post-hoc evidence from this study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies. FUNDING: Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India.


Subject(s)
Antibodies, Monoclonal, Humanized , COVID-19 , Cytokine Release Syndrome , Receptors, Interleukin-6/antagonists & inhibitors , Respiratory Distress Syndrome , SARS-CoV-2/isolation & purification , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/complications , COVID-19/immunology , COVID-19/mortality , COVID-19/therapy , Critical Care/methods , Cytokine Release Syndrome/drug therapy , Cytokine Release Syndrome/etiology , Cytokine Release Syndrome/immunology , Drug Monitoring/methods , Female , Humans , Immunologic Factors/administration & dosage , Immunologic Factors/adverse effects , India , Male , Middle Aged , Mortality , Respiration, Artificial/methods , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/etiology , Severity of Illness Index , Treatment Outcome
7.
JAMA ; 326(18): 1807-1817, 2021 11 09.
Article in English | MEDLINE | ID: covidwho-1527380

ABSTRACT

Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.


Subject(s)
COVID-19 Drug Treatment , Dexamethasone/administration & dosage , Glucocorticoids/administration & dosage , Life Support Care , Aged , COVID-19/complications , COVID-19/mortality , Dexamethasone/adverse effects , Dose-Response Relationship, Drug , Female , Glucocorticoids/adverse effects , Humans , Hypoxia/etiology , Hypoxia/therapy , Male , Middle Aged , Mycoses/etiology , Respiration, Artificial , Shock, Septic/etiology , Single-Blind Method
8.
Med Sci (Basel) ; 9(4)2021 10 26.
Article in English | MEDLINE | ID: covidwho-1488672

ABSTRACT

Background Diabetes mellitus (DM) is a decisive risk factor for severe illness in coronavirus disease 2019 (COVID-19). India is home to a large number of people with DM, and many of them were infected with COVID-19. It is critical to understand the impact of DM on mortality and other clinical outcomes of COVID-19 infection from this region. Aims The primary objective of our study was to analyze the mortality rate in people with DM infected with COVID-19. The secondary objectives were to assess the effect of various comorbidities on mortality and study the impact of DM on other clinical outcomes. Methods This is a retrospective study of COVID-19 infected patients admitted to a tertiary care hospital in north India in the early phase of the pandemic. Results Of the 1211 cases admitted, 19 were excluded because of incomplete data, and 1192 cases were finally considered for analysis. DM constituted 26.8% of total patients. The overall mortality rate was 6.1%, and the rate was 10.7% in the presence of diabetes (p < 0.01, OR 2.55). In univariate analysis, increased age, chronic kidney disease (CKD), coronary artery disease (CAD), stroke, and cancer were associated with mortality. On multiple logistic regression, the independent predictors of mortality were CAD, CKD, and cancer. Breathlessness and low SpO2 at presentation, extensive involvement in CXR, and elevated ANC/ALC ratio were also significantly associated with mortality. Conclusions The presence of comorbidities such as DM, hypertension, CAD, CKD, and cancer strongly predict the risk of mortality in COVID-19 infection. Early triaging and aggressive therapy of patients with these comorbidities can optimize clinical outcomes.


Subject(s)
COVID-19 , Diabetes Mellitus , COVID-19/mortality , Comorbidity , Coronary Artery Disease/complications , Diabetes Mellitus/mortality , Diabetes Mellitus/virology , Humans , Neoplasms/complications , Renal Insufficiency, Chronic/complications , Retrospective Studies
9.
Sci Rep ; 11(1): 12801, 2021 06 17.
Article in English | MEDLINE | ID: covidwho-1275956

ABSTRACT

In Coronavirus disease 2019 (COVID-19), early identification of patients with a high risk of mortality can significantly improve triage, bed allocation, timely management, and possibly, outcome. The study objective is to develop and validate individualized mortality risk scores based on the anonymized clinical and laboratory data at admission and determine the probability of Deaths at 7 and 28 days. Data of 1393 admitted patients (Expired-8.54%) was collected from six Apollo Hospital centers (from April to July 2020) using a standardized template and electronic medical records. 63 Clinical and Laboratory parameters were studied based on the patient's initial clinical state at admission and laboratory parameters within the first 24 h. The Machine Learning (ML) modelling was performed using eXtreme Gradient Boosting (XGB) Algorithm. 'Time to event' using Cox Proportional Hazard Model was used and combined with XGB Algorithm. The prospective validation cohort was selected of 977 patients (Expired-8.3%) from six centers from July to October 2020. The Clinical API for the Algorithm is  http://20.44.39.47/covid19v2/page1.php being used prospectively. Out of the 63 clinical and laboratory parameters, Age [adjusted hazard ratio (HR) 2.31; 95% CI 1.52-3.53], Male Gender (HR 1.72, 95% CI 1.06-2.85), Respiratory Distress (HR 1.79, 95% CI 1.32-2.53), Diabetes Mellitus (HR 1.21, 95% CI 0.83-1.77), Chronic Kidney Disease (HR 3.04, 95% CI 1.72-5.38), Coronary Artery Disease (HR 1.56, 95% CI - 0.91 to 2.69), respiratory rate > 24/min (HR 1.54, 95% CI 1.03-2.3), oxygen saturation below 90% (HR 2.84, 95% CI 1.87-4.3), Lymphocyte% in DLC (HR 1.99, 95% CI 1.23-2.32), INR (HR 1.71, 95% CI 1.31-2.13), LDH (HR 4.02, 95% CI 2.66-6.07) and Ferritin (HR 2.48, 95% CI 1.32-4.74) were found to be significant. The performance parameters of the current model is at AUC ROC Score of 0.8685 and Accuracy Score of 96.89. The validation cohort had the AUC of 0.782 and Accuracy of 0.93. The model for Mortality Risk Prediction provides insight into the COVID Clinical and Laboratory Parameters at admission. It is one of the early studies, reflecting on 'time to event' at the admission, accurately predicting patient outcomes.


Subject(s)
COVID-19/epidemiology , COVID-19/mortality , Machine Learning , Patient Admission , SARS-CoV-2 , Aged , COVID-19/virology , Electronic Health Records , Female , Humans , India/epidemiology , Male , Middle Aged , Prognosis , Propensity Score , Proportional Hazards Models , Prospective Studies , Retrospective Studies , Risk Assessment , Risk Factors , Triage
10.
Acta Anaesthesiol Scand ; 65(6): 834-845, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1083073

ABSTRACT

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear. METHODS: The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol. DISCUSSION: The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.


Subject(s)
Anti-Inflammatory Agents/administration & dosage , COVID-19 Drug Treatment , Dexamethasone/administration & dosage , Pandemics , Randomized Controlled Trials as Topic/methods , SARS-CoV-2 , Anti-Inflammatory Agents/adverse effects , COVID-19/complications , Denmark , Dexamethasone/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Hospital Mortality , Humans , Hydrocortisone/therapeutic use , Hypoxia/drug therapy , Hypoxia/etiology , India , Life Support Care/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Quality of Life , Survival Analysis , Sweden , Switzerland
11.
Acta Anaesthesiol Scand ; 65(5): 702-710, 2021 05.
Article in English | MEDLINE | ID: covidwho-1081822

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) can lead to severe hypoxic respiratory failure and death. Corticosteroids decrease mortality in severely or critically ill patients with COVID-19. However, the optimal dose remains unresolved. The ongoing randomised COVID STEROID 2 trial investigates the effects of higher vs lower doses of dexamethasone (12 vs 6 mg intravenously daily for up to 10 days) in 1,000 adult patients with COVID-19 and severe hypoxia. METHODS: This protocol outlines the rationale and statistical methods for a secondary, pre-planned Bayesian analysis of the primary outcome (days alive without life support at day 28) and all secondary outcomes registered up to day 90. We will use hurdle-negative binomial models to estimate the mean number of days alive without life support in each group and present results as mean differences and incidence rate ratios with 95% credibility intervals (CrIs). Additional count outcomes will be analysed similarly and binary outcomes will be analysed using logistic regression models with results presented as probabilities, relative risks and risk differences with 95% CrIs. We will present probabilities of any benefit/harm, clinically important benefit/harm and probabilities of effects smaller than pre-defined clinically minimally important differences for all outcomes analysed. Analyses will be adjusted for stratification variables and conducted using weakly informative priors supplemented by sensitivity analyses using sceptic priors. DISCUSSION: This secondary, pre-planned Bayesian analysis will supplement the primary, conventional analysis and may help clinicians, researchers and policymakers interpret the results of the COVID STEROID 2 trial while avoiding arbitrarily dichotomised interpretations of the results. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04509973; EudraCT: 2020-003363-25.


Subject(s)
COVID-19 Drug Treatment , Dexamethasone/administration & dosage , Hypoxia/drug therapy , Randomized Controlled Trials as Topic , SARS-CoV-2 , Bayes Theorem , Humans
12.
Indian J Crit Care Med ; 24(12): 1174-1179, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-993963

ABSTRACT

INTRODUCTION: Coronavirus disease-2019 (COVID-19) systemic illness caused by a novel coronavirus severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has been spreading across the world. The objective of this study is to identify the clinical and laboratory variables as predictors of in-hospital death at the time of admission in a tertiary care hospital in India. MATERIALS AND METHODS: Demographic profile, clinical, and laboratory variables of 425 patients admitted from April to June 2020 with symptoms and laboratory-confirmed diagnosis through real-time polymerase chain reaction (RT-PCR) were studied. Descriptive statistics, an association of these variables, logistic regression, and CART models were developed to identify early predictors of in-hospital death. RESULTS: Twenty-two patients (5.17%) had expired in course of their hospital stay. The median age [interquartile range (IQR)] of the patients admitted was 49 years (21-77 years). Gender distribution was male - 73.38% (mortality rate 5.83%) and female-26.62% (mortality rate 3.34%). The study shows higher association for age (>47 years) [odds ratio (OR) 4.52], male gender (OR 1.78), shortness of breath (OR 2.02), oxygen saturation <93% (OR 9.32), respiratory rate >24 (OR 5.31), comorbidities like diabetes (OR 2.70), hypertension (OR 2.12), and coronary artery disease (OR 3.18) toward overall mortality. The significant associations in laboratory variables include lymphopenia (<12%) (OR 8.74), C-reactive protein (CRP) (OR 1.99), ferritin (OR 3.18), and lactate dehydrogenase (LDH) (OR 3.37). Using this statistically significant 16 clinical and laboratory variables, the logistic regression model had an area under receiver operating characteristic (ROC) curve of 0.86 (train) and 0.75 (test). CONCLUSION: Age above 47 years, associated with comorbidities like hypertension and diabetes, with oxygen saturation below 93%, tachycardia, and deranged laboratory variables like lymphopenia and raised CRP, LDH, and ferritin are important predictors of in-hospital mortality. HOW TO CITE THIS ARTICLE: Jain AC, Kansal S, Sardana R, Bali RK, Kar S, Chawla R. A Retrospective Observational Study to Determine the Early Predictors of In-hospital Mortality at Admission with COVID-19. Indian J Crit Care Med 2020;24(12):1174-1179.

13.
Indian J Crit Care Med ; 24(8): 609-610, 2020 Aug.
Article in English | MEDLINE | ID: covidwho-836354

ABSTRACT

How to cite this article: Chawla R, Nasa P. Ventilatory Management of COVID-19-related ARDS: Stick to Basics and Infection Control. Indian J Crit Care Med 2020;24(8):609-610.

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