Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome

Phase 3 Completed 200 enrolled National Heart, Lung, and Blood Institute (NHLBI)

RandomizedFactorialDouble-blindTreatment

Summary

The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.

Timeline

Start: 1997-03
Primary completion: —
Completion: 2005-09

Outcome

Missed primary endpoint

paper 29.2 percent in the methylprednisolone group (95 percent confidence interval, 20.8 to 39.4 percent; P=1.0) PMID 16625008 ↗

Publications

Results Steinberg KP, Hudson LD, Goodman RB, Hough CL, Lanken PN, Hyzy R, Thompson BT, Ancukiewicz M; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med. 2006 Apr 20;354(16):1671-84. doi: 10.1056/NEJMoa051693.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylprednisolone	Other / unclassified	—	—