Acute Respiratory Distress Syndrome Clinical Trial
To assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome as well as those at risk of developing ARDS.
BACKGROUND:
Adult respiratory distress syndrome 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 has remained greater than 50 percent. Many of the patients are young, and in
addition to the tragic loss of human life, can be added the 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 would appear to be the most effective strategy for improving the
outlook in this condition.
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 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. The
complicated clinical picture makes it difficult to accumulate a large number of comparable
patients in any one center. There is no agreement on the optimal supportive care of these
critically ill patients. 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:
Network investigators have developed a plan for a new protocol to assess the Pulmonary
Artery Catheter as a management tool in ARDS. The new study was prompted by recommendations
from the FDA/NIH Pulmonary Artery Catheter Clinical Outcomes workshop convened in August
1997 in response to concerns in the medical community regarding the clinical benefit and
safety of pulmonary artery catheters. The new protocol in the Fluids and Catheters Treatment
Trial (FACTT) is a two by two factorial design comparing the patients receiving PAC or a
central venous catheter (CVC) with one of two fluid management strategies (conservative vs.
liberal). The randomized, multicenter trial is designed to include 1000 patients. The
primary endpoint is mortality at 60 days. Secondary endpoints include ventilator free days
and organ failure free days.
;
Intervention Model: Factorial Assignment, Primary Purpose: Treatment
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