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10.1001/jama.2020.17021

http://scihub22266oqcxt.onion/10.1001/jama.2020.17021
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32876695!7489411!32876695
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suck abstract from ncbi


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pmid32876695      JAMA 2020 ; 324 (13): 1307-1316
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  • Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial #MMPMID32876695
  • Tomazini BM; Maia IS; Cavalcanti AB; Berwanger O; Rosa RG; Veiga VC; Avezum A; Lopes RD; Bueno FR; Silva MVAO; Baldassare FP; Costa ELV; Moura RAB; Honorato MO; Costa AN; Damiani LP; Lisboa T; Kawano-Dourado L; Zampieri FG; Olivato GB; Righy C; Amendola CP; Roepke RML; Freitas DHM; Forte DN; Freitas FGR; Fernandes CCF; Melro LMG; Junior GFS; Morais DC; Zung S; Machado FR; Azevedo LCP
  • JAMA 2020[Oct]; 324 (13): 1307-1316 PMID32876695show ga
  • IMPORTANCE: Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung injury in these patients. OBJECTIVE: To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients. INTERVENTIONS: Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148). MAIN OUTCOMES AND MEASURES: The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days. RESULTS: A total of 299 patients (mean [SD] age, 61 [14] years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. CONCLUSIONS AND RELEVANCE: Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04327401.
  • |Administration, Intravenous[MESH]
  • |Aged[MESH]
  • |Anti-Inflammatory Agents/adverse effects/*therapeutic use[MESH]
  • |Betacoronavirus[MESH]
  • |Brazil[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Drug Treatment[MESH]
  • |Catheter-Related Infections/epidemiology[MESH]
  • |Coronavirus Infections/complications/*drug therapy/mortality/therapy[MESH]
  • |Dexamethasone/adverse effects/*therapeutic use[MESH]
  • |Early Termination of Clinical Trials[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/complications/*drug therapy/mortality/therapy[MESH]
  • |Respiration, Artificial/*statistics & numerical data[MESH]
  • |Respiratory Distress Syndrome/*drug therapy/etiology[MESH]


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