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

Condition Intervention Phase
Acute Respiratory Distress Syndrome
Lung Diseases
Procedure: pulmonary artery catheter
Procedure: central venous catheter
Procedure: fluid management
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Factorial Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281268

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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00281268     History of Changes
Other Study ID Numbers: 356 
Study First Received: January 20, 2006
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on August 24, 2016