Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network
NCT ID: NCT00281268
Last Updated: 2008-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2005-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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FACTORIAL
TREATMENT
Interventions
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pulmonary artery catheter
central venous catheter
fluid management
Eligibility Criteria
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Inclusion Criteria
13 Years
ALL
No
Sponsors
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ARDSNet
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Principal Investigators
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Edward Abraham
Role:
University of Colorado, Denver
Antonio Anzueto
Role:
University of Texas
Alfred Connors
Role:
University of Virginia
Bennett deBoisblanc
Role:
Louisiana State University Health Sciences Center in New Orleans
Michael Donahoe
Role:
University of Pittsburgh
William Fulkerson
Role:
Duke University
Kalpalatha Guntupalli
Role:
Baylor College of Medicine
Robert Hite
Role:
Wake Forest University
Leonard Hudson
Role:
University of Washington
Paul Lanken
Role:
University of Pennsylvania
Michael Matthay
Role:
University of California
Alan Morris
Role:
Latter Day Saints Hospital
James Russell
Role:
University of British Columbia
Gregory Schmidt
Role:
University of Chicago
David Schoenfeld
Role:
Massachusetts General Hospital
Henry Silverman
Role:
University of Maryland
Jay Steingrub
Role:
Baystate Medical Center
Galen Toews
Role:
University of Michigan
Arthur Wheeler
Role:
Vanderbilt University
Herbert Wiedemann
Role:
The Cleveland Clinic
References
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Bhatraju P, Hsu C, Mukherjee P, Glavan BJ, Burt A, Mikacenic C, Himmelfarb J, Wurfel M. Associations between single nucleotide polymorphisms in the FAS pathway and acute kidney injury. Crit Care. 2015 Oct 19;19:368. doi: 10.1186/s13054-015-1084-5.
Stewart RM, Park PK, Hunt JP, McIntyre RC Jr, McCarthy J, Zarzabal LA, Michalek JE; National Institutes of Health/National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Less is more: improved outcomes in surgical patients with conservative fluid administration and central venous catheter monitoring. J Am Coll Surg. 2009 May;208(5):725-35; discussion 735-7. doi: 10.1016/j.jamcollsurg.2009.01.026. Epub 2009 Mar 31.
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wheeler AP, Bernard GR, Thompson BT, Schoenfeld D, Wiedemann HP, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Pulmonary-artery versus central venous catheter to guide treatment of acute lung injury. N Engl J Med. 2006 May 25;354(21):2213-24. doi: 10.1056/NEJMoa061895. Epub 2006 May 21.
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
Related Links
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Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
Other Identifiers
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356
Identifier Type: -
Identifier Source: org_study_id
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