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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281268
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : January 21, 2008
Sponsor:
Collaborator:
ARDSNet
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE January 20, 2006
First Posted Date  ICMJE January 24, 2006
Last Update Posted Date January 21, 2008
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network
Official Title  ICMJE Not Provided
Brief Summary To assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome as well as those at risk of developing ARDS.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Lung Diseases
Intervention  ICMJE
  • Procedure: pulmonary artery catheter
  • Procedure: central venous catheter
  • Procedure: fluid management
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00281268
Other Study ID Numbers  ICMJE 356
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE ARDSNet
Investigators  ICMJE
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 University
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, College Park
Investigator: Jay Steingrub Baystate Medical Center
Investigator: Galen Toews University of Michigan
Investigator: Arthur Wheeler Vanderbilt University
Investigator: Herbert Wiedemann The Cleveland Clinic
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date January 2008

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