The COVID STEROID 2 Trial Group 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 MEASURESThe 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 Ն1 serious adverse reactions at 28 days). RESULTSOf 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.

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Aims:To obtain information on organizational aspects, case mix and practices in Indian Intensive Care Units (ICUs).Patients and Methods:An observational, 4-day point prevalence study was performed between 2010 and 2011 in 4209 patients from 124 ICUs. ICU and patient characteristics, and interventions were recorded for 24 h of the study day, and outcomes till 30 days after the study day. Data were analyzed for 4038 adult patients from 120 ICUs.Results:On the study day, mean age, Acute Physiology and Chronic Health Evaluation (APACHE II) and sequential organ failure assessment (SOFA) scores were 54.1 ± 17.1 years, 17.4 ± 9.2 and 3.8 ± 3.6, respectively. About 46.4% patients had ≥1 organ failure. Nearly, 37% and 22.2% patients received mechanical ventilation (MV) and vasopressors or inotropes, respectively. Nearly, 12.2% patients developed an infection in the ICU. About 28.3% patients had severe sepsis or septic shock (SvSpSS) during their ICU stay. About 60.7% patients without infection received antibiotics. There were 546 deaths and 183 terminal discharges (TDs) from ICU (including left against medical advice or discharged on request), with ICU mortality 729/4038 (18.1%). In 1627 patients admitted within 24 h of the study day, the standardized mortality ratio was 0.67. The APACHE II and SOFA scores, public hospital ICUs, medical ICUs, inadequately equipped ICUs, medical admission, self-paying patient, presence of SvSpSS, acute respiratory failure or cancer, need for a fluid bolus, and MV were independent predictors of mortality.Conclusions:The high proportion of TDs and the association of public hospitals, self-paying patients, and inadequately equipped hospitals with mortality has important implications for critical care in India.