Acute Respiratory Distress Network Study 02 (ARDSNet 02) Late Steroid Rescue Study (LaSRS)
Website: http://www.ardsnet.org/
Clinical Trials URL:
http://clinicaltrials.gov/ct2/show/...
Study Type:
Clinical Trial
Prepared on October 13, 2008
Last Updated on August 24, 2006
Study Dates: 1997-2003
Consent: Restricted Consent
Consent Restrictions: Consent is tiered regarding genetic research.
Commercial Use Restrictions:
No
NHLBI Division: DLD
Collection Type: Open BioLINCC Study
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Objectives
Since previous reports suggested that corticosteroids may improve survival, this project was developed as a multicenter, randomized controlled trial of corticosteroids in patients with persistent ARDS.
Background
Persistent acute respiratory distress syndrome (ARDS) is characterized by excessive fibroproliferation, ongoing inflammation, prolonged mechanical ventilation, and a substantial risk of death.
Subjects
180 randomly assigned patients with ARDS of at least seven days duration received either methylprednisolone or placebo in a double-blind fashion. The primary end point was mortality at 60 days.
Conclusions
The results do not support the routine use of methylprednisolone for persistent ARDS despite the improvement in cardiopulmonary physiology. In addition, starting methylprednisolone therapy more than two weeks after the onset of ARDS may increase the risk of death. (NEJM April 20, 2006; Vol 354, No. 16, pp 1671-84)