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Sponsors and Collaborators: |
University of Washington National Heart, Lung, and Blood Institute (NHLBI) American Thoracic Society Acute Respiratory Distress Syndrome Foundation American Society for Parenteral and Enteral Nutrition |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00351533 |
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.
Condition | Intervention | Phase |
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Respiratory Distress Syndrome, Adult Acute Lung Injury Acute Respiratory Distress Syndrome |
Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | A Randomized, Double-Blind Study of the Effect of Fish Oil (Eicosapentaenoic Acid and Docosahexanoic Acid) on Lung and Systemic Inflammation in Patients With Acute Lung Injury (ALI) |
Estimated Enrollment: | 90 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Enteral fish oil
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Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
Liquid fish oil 7.5cc enterally every 6 hours
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2: Placebo Comparator
Saline
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Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
Liquid fish oil 7.5cc enterally every 6 hours
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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 therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically there is plausible biologic rationale for administering n-3 fatty acids (n-3 FAs) found in fish oil to patients with ALI, as n-3 FAs decrease formation of eicosanoid inflammatory mediators. However, although promising results have emerged from prior studies, fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients, and the control group received a high-fat enteral formula that may have been proinflammatory. Therefore, no conclusion can be drawn about the independent effect of fish oils. Furthermore, the inclusion of key pharmaconutrients in feeding formulas, instead of delivering them separately as pharmaceuticals, limits exposure to the agent, as ICU patients commonly receive less than 60% of prescribed caloric needs. Finally, specialized feeding formulas are very expensive, and it may be substantially cheaper to administer pharmaconutrients separately. We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals. With appropriate scientific investigation and the use of non-nutrient placebos, this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients.
This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), both n-3 FAs found in fish oil, versus placebo on the pulmonary and systemic environments, and on clinical outcomes, in patients with ALI. We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum, on pulmonary physiologic outcomes, and on clinical outcomes.
Comparison(s): Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Renee D. Stapleton, MD, MSc | 206-849-4843 | rstaplet@u.washington.edu |
Contact: Stephanie Gundel, RD | 206-341-4041 | sgundel@u.washington.edu |
United States, Idaho | |
St. Alphonsus Medical Center | Recruiting |
Boise, Idaho, United States, 83706 | |
Contact: Joseph Crowley, MD 208-855-1002 josecrow@cableone.net | |
Principal Investigator: Joseph Crowley, MD | |
United States, Oregon | |
Oregon Health Sciences University | Completed |
Portland, Oregon, United States, 97239 | |
United States, Vermont | |
University of Vermont/Fletcher Allen Health Care | Recruiting |
Burlington, Vermont, United States, 05401 | |
Contact: Renee D. Stapleton, MD, MSc 206-849-4843 renee.stapleton@uvm.edu | |
Principal Investigator: Renee D. Stapleton, MD, MSc | |
United States, Washington | |
Harborview Medical Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Stephanie Gundel, RD 206-341-4041 sgundel@u.washington.edu | |
Principal Investigator: Margaret J. Neff, MD, MSc | |
Sub-Investigator: Renee D. Stapleton, MD MSc | |
Canada, Ontario | |
St. Michael's Hospital | Completed |
Toronto, Ontario, Canada, M5B1W8 |
Principal Investigator: | Renee D. Stapleton, MD, MSc | University of Vermont |
Responsible Party: | University of Washington ( Renee D. Stapleton ) |
Study ID Numbers: | 05-7895-A 03 |
Study First Received: | July 11, 2006 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00351533 |
Health Authority: | United States: Institutional Review Board |
Respiratory distress syndrome, adult Acute lung injury Acute respiratory distress syndrome ARDS, human |
Fish oils Fatty Acids, Omega-3 Docosahexaenoic Acids Eicosapentaenoic Acid |
Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome Inflammation |
Pathologic Processes Disease Syndrome |