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

• ClinicalTrials.gov Identifier: NCT00281268
• Recruitment Status: Completed
• First Posted: January 24, 2006
• Last Update Posted: January 21, 2008
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborator: ARDSNet
• Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Study Description

Brief Summary:

To assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome as well as those at risk of developing ARDS.

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Distress Syndrome; Lung Diseases	Procedure: pulmonary artery catheter; Procedure: central venous catheter; Procedure: fluid management	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Intervention Model: Factorial Assignment
• Primary Purpose: Treatment
• Actual Primary Completion Date: October 2005
• Actual Study Completion Date: October 2005

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

ARDSNet

Investigators

• OverallOfficial: Edward Abraham; University of Colorado, Denver
• OverallOfficial: Antonio Anzueto; University of Texas
• OverallOfficial: Alfred Connors; University of Virginia
• OverallOfficial: Bennett deBoisblanc; Louisiana State University Health Sciences Center in New Orleans
• OverallOfficial: Michael Donahoe; University of Pittsburgh
• OverallOfficial: William Fulkerson; Duke University
• OverallOfficial: Kalpalatha Guntupalli; Baylor College of Medicine
• OverallOfficial: Robert Hite; Wake Forest University
• OverallOfficial: Leonard Hudson; University of Washington
• OverallOfficial: Paul Lanken; University of Pennsylvania
• OverallOfficial: Michael Matthay; University of California
• OverallOfficial: Alan Morris; Latter Day Saints Hospital
• OverallOfficial: James Russell; University of British Columbia
• OverallOfficial: Gregory Schmidt; University of Chicago
• OverallOfficial: David Schoenfeld; Massachusetts General Hospital
• OverallOfficial: Henry Silverman; University of Maryland
• OverallOfficial: Jay Steingrub; Baystate Medical Center
• OverallOfficial: Galen Toews; University of Michigan
• OverallOfficial: Arthur Wheeler; Vanderbilt University
• OverallOfficial: Herbert Wiedemann; The Cleveland Clinic

More Information

Additional Information:

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: J Am Coll Surg. 2009 Aug;209(2):295.

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.

• ClinicalTrials.gov Identifier: NCT00281268
• Other Study ID Numbers: 356
• First Posted: January 24, 2006
• Last Update Posted: January 21, 2008
• Last Verified: January 2008

Additional relevant MeSH terms:

Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury