Acute Respiratory Distress SyndromePhase 3NCT00281268
Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network
A Phase 3 study testing pulmonary artery catheter, central venous catheter and fluid management in people with Acute Respiratory Distress Syndrome and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome as well as those at risk of developing ARDS. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Lung Diseases
- What is being tested?
- pulmonary artery catheter, central venous catheter and fluid management
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
About this study
To assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome as well as those at risk of developing ARDS.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome, Lung Diseases
- Being tested
- pulmonary artery catheter, central venous catheter, fluid management
- Medical subject headings
- Respiratory Distress Syndrome, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary artery catheterProcedure or surgery
central venous catheterProcedure or surgery
fluid managementProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Intervention model
- Factorial
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- ARDSNet
- Investigators
- Edward Abraham, University of Colorado, DenverAntonio Anzueto, University of TexasAlfred Connors, University of VirginiaBennett deBoisblanc, Louisiana State University Health Sciences Center in New OrleansMichael Donahoe, University of PittsburghWilliam Fulkerson, Duke UniversityKalpalatha Guntupalli, Baylor College of MedicineRobert Hite, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281268
- Sponsor's protocol ID
- 356
- Status last verified
- Jan 2008
- First submitted
- 20 Jan 2006
- Last updated
- 21 Jan 2008
- Results posted
- No
Publications
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.
PubMed 26477820Stewart 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.
PubMed 19476825National 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.
PubMed 16714768National 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.
PubMed 16714767
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluids and Catheters Treatment Trial (FACTT) - ARDS Clinical Research Network
- ClinicalTrials.gov ID
- NCT00281268
- Acronym / sponsor ID
- 356
- Conditions
- Acute Respiratory Distress Syndrome, Lung Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- ARDSNet
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Factorial
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary artery catheter | Procedure or surgery | – |
| central venous catheter | Procedure or surgery | – |
| fluid management | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2008.
- Derived from this study: PubMed 26477820Bhatraju 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.
- Derived from this study: PubMed 19476825Stewart 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.
- Derived from this study: PubMed 16714768National 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.
- Derived from this study: PubMed 16714767National 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.
- Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Abraham
University of Colorado, Denver
Antonio Anzueto
University of Texas
Alfred Connors
University of Virginia
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pulmonary artery catheter, central venous catheter and fluid management in people with Acute Respiratory Distress Syndrome and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00281268, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2008.