Status:
COMPLETED
A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
American Thoracic Society
Conditions:
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.
Detailed Description
Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new...
Eligibility Criteria
Inclusion
- Requiring positive-pressure mechanical ventilation
- ALI criteria: PaO2/FiO2 \<300, bilateral infiltrates on chest radiograph, no left atrial hypertension
- Age \> 17 years
Exclusion
- Expected ICU length of stay \<48 hours
- Unable to undergo bronchoalveolar lavage at enrollment
- Unable to obtain enteral access
- Post-cardiac arrest with suspected significant anoxic brain injury
- Expected survival \< 28 days
- Pregnant
- Platelet count \< 30,000, active bleeding, or international normalized ratio (INR)\>3.0
- History of ventricular tachycardia or fibrillation
- Receiving recombinant human activated protein C (rh-APC) for sepsis
- Acquired immune deficiency syndrome (AIDS) with CD4 count \< 200
- Metastatic cancer
- History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00351533
Start Date
July 1 2006
End Date
August 1 2009
Last Update
October 3 2011
Active Locations (5)
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1
St. Alphonsus Medical Center
Boise, Idaho, United States, 83706
2
Oregon Health Sciences University
Portland, Oregon, United States, 97239
3
University of Vermont/Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
4
Harborview Medical Center
Seattle, Washington, United States, 98104