Ards protocol steroids

Results  We identified 17 randomized trials (n = 2138) and 3 quasi-randomized trials (n = 246) that had acceptable methodological quality to pool in a meta-analysis. Twenty-eight-day mortality for treated vs control patients was 388/1099 (%) vs 400/1039 (%) in randomized trials (risk ratio [RR], ; 95% confidence interval [CI], -; P =.05; I 2 =53% by random-effects model) and 28/121 (%) vs 24/125 (%) in quasi-randomized trials (RR, , 95% CI, -; P  = .83). In 12 trials investigating prolonged low-dose corticosteroid treatment, 28-day mortality for treated vs control patients was 236/629 (%) vs 264/599 (44%) (RR, ; 95% CI, -; P  = .02). This treatment increased 28-day shock reversal (6 trials; 322/481 [%] vs 276/471 [%]; RR, ; 95% CI, -; P  = .02; I 2  = 4%) and reduced intensive care unit length of stay by days (8 trials; 95% CI, – to –; P  < .001; I 2  = 0%) without increasing the risk of gastroduodenal bleeding (13 trials; 65/800 [%] vs 56/764 [%]; P  = .50; I 2  = 0%), superinfection (14 trials; 184/998 [%] vs 170/950 [%]; P  = .92; I 2  = 8%), or neuromuscular weakness (3 trials; 4/407 [1%] vs 7/404 [%]; P  = .58; I 2  = 30%). Corticosteroids increased the risk of hyperglycemia (9 trials; 363/703 [%] vs 308/670 [46%]; P  < .001; I 2  = 0%) and hypernatremia (3 trials; 127/404 [%] vs 77/401 [%]; P  < .001; I 2  = 0%).

On July 3, 2003 the OHRP published its determinations from the subsequent inquiry. In its most important finding, OHRP said "… almost all of the consultants engaged by OHRP opined that risks to subjects in the ARMA [tidal volume] trial were minimized and reasonable in relation to anticipated benefits to the subjects and the importance of the knowledge that was expected to result." The OHRP consultants expressed the same opinion regarding the ARDS Network fluids and catheters treatment trial (FACTT). The OHRP consultants’ findings were consistent with those of the 5 independent consultants engaged by the NHLBI who, on August 30, 2002 concluded unanimously that the ARDS Network trials were safe and appropriately designed. The OHRP determination letter requested that all IRBs review additional background materials pertinent to the FACTT study, examine their practices, and requested changes to the FACTT consent forms. FACTT was resumed without changes to the trial design or procedures after these actions were completed.

Ards protocol steroids

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