Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
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.
BACKGROUND:
ARDS affects approximately 150,000 people in the United States each year. Despite twenty
years of research into the mechanisms that cause this syndrome and numerous developments in
the technology of mechanical ventilation, the mortality rate has remained greater than 50
percent. In addition to the tragic loss of human life, this condition poses a cost to
society because these patients spend an average of two weeks in intensive care units and
require multiple high tech procedures. Because of the overwhelming nature of the lung injury
once it is established, prevention appears to be the most effective strategy for improving
the outlook for those with ARDS.
Basic research has identified numerous inflammatory pathways that are associated with the
development of ARDS. Agents that block these mediators prolong survival in animals with lung
injury, and a few of them have been tested in human patients. Because of the large number of
putative mediators and the variety of ways that their action can be blocked, the possibility
for new drug development is almost infinite. This is an exciting prospect, since it
envisions the first effective pharmacologic treatment for ARDS. However, preliminary
clinical studies have shown conflicting results, and there is an urgent need for a mechanism
to efficiently and effectively test new drugs in ARDS. Treatment studies in patients with
ARDS are difficult to perform for three reasons. First, the complicated clinical picture
makes it difficult to accumulate a large number of comparable patients in any one center.
Secondly, there is no agreement on the optimal supportive care of these critically ill
patients. Finally, many of the patients meeting study criteria will not be enrolled in study
protocols because of the acute nature of the disease process. For these reasons, therapeutic
trials in ARDS require multicenter cooperation.
DESIGN NARRATIVE:
This study compared the effect of corticosteroids with placebo in the management of
late-phase (greater than seven days) ARDS. The study determined if the administration of the
corticosteroid, methylprednisolone sodium succinate, in severe ARDS that was either stable
or worsening after seven days, would reduce mortality and morbidity. The primary endpoint
was mortality at 60 days. Secondary endpoints included ventilator-free days and organ
failure-free days. LaSRS was designed to include 400 patients and began recruiting in the
Spring of 1997. In October 1999, the data and safety monitoring board (DSMB) reduced the
recruitment target number to 200 patients because the eligible patients were fewer than
anticipated.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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