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Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network

This study has been completed.
Sponsor:
Collaborator:
ARDSNet
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00281268
First received: January 20, 2006
Last updated: January 18, 2008
Last verified: January 2008

January 20, 2006
January 18, 2008
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October 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00281268 on ClinicalTrials.gov Archive Site
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Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network
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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.

Interventional
Phase 3
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
  • Acute Respiratory Distress Syndrome
  • Lung Diseases
  • Procedure: pulmonary artery catheter
  • Procedure: central venous catheter
  • Procedure: fluid management
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2005
October 2005   (final data collection date for primary outcome measure)

Men and women, 13 years of age or older, with ARDS or risk factors for ARDS. Patients will be considered at risk if they are critically ill and have trauma, sepsis, shock, pneumonia, inhalation injury, drug overdose, pancreatitis, hypertransfusion.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00281268
356
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National Heart, Lung, and Blood Institute (NHLBI)
ARDSNet
Investigator: Edward Abraham University of Colorado, Denver
Investigator: Antonio Anzueto University of Texas
Investigator: Alfred Connors University of Virginia
Investigator: Bennett deBoisblanc Louisiana State University Health Sciences Center in New Orleans
Investigator: Michael Donahoe University of Pittsburgh
Investigator: William Fulkerson Duke University
Investigator: Kalpalatha Guntupalli Baylor College of Medicine
Investigator: Robert Hite Wake Forest School of Medicine
Investigator: Leonard Hudson University of Washington
Investigator: Paul Lanken University of Pennsylvania
Investigator: Michael Matthay University of California
Investigator: Alan Morris Latter Day Saints Hospital
Investigator: James Russell University of British Columbia
Investigator: Gregory Schmidt University of Chicago
Investigator: David Schoenfeld Massachusetts General Hospital
Investigator: Henry Silverman University of Maryland
Investigator: Jay Steingrub Baystate Medical Center
Investigator: Galen Toews University of Michigan
Investigator: Arthur Wheeler Vanderbilt University
Investigator: Herbert Wiedemann The Cleveland Clinic
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP