Abstract | CONTEXT: OBJECTIVE: To determine if dietary supplementation of these substances to patients with acute lung injury would increase ventilator-free days to study day 28. DESIGN, SETTING, AND PARTICIPANTS: The OMEGA study, a randomized, double-blind, placebo-controlled, multicenter trial conducted from January 2, 2008, through February 21, 2009. Participants were 272 adults within 48 hours of developing acute lung injury requiring mechanical ventilation whose physicians intended to start enteral nutrition at 44 hospitals in the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. All participants had complete follow-up. INTERVENTIONS: MAIN OUTCOME MEASURE: RESULTS: The study was stopped early for futility after 143 and 129 patients were enrolled in the n-3 and control groups. Despite an 8-fold increase in plasma eicosapentaenoic acid levels, patients receiving the n-3 supplement had fewer ventilator-free days (14.0 vs 17.2; P = .02) (difference, -3.2 [95% CI, -5.8 to -0.7]) and intensive care unit-free days (14.0 vs 16.7; P = .04). Patients in the n-3 group also had fewer nonpulmonary organ failure-free days (12.3 vs 15.5; P = .02). Sixty-day hospital mortality was 26.6% in the n-3 group vs 16.3% in the control group (P = .054), and adjusted 60-day mortality was 25.1% and 17.6% in the n-3 and control groups, respectively ( P = .11). Use of the n-3 supplement resulted in more days with diarrhea (29% vs 21%; P = .001). CONCLUSIONS: TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00609180.
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Authors | Todd W Rice, Arthur P Wheeler, B Taylor Thompson, Bennett P deBoisblanc, Jay Steingrub, Peter Rock, NIH NHLBI Acute Respiratory Distress Syndrome Network of Investigators, NHLBI ARDS Clinical Trials Network |
Journal | JAMA
(JAMA)
Vol. 306
Issue 14
Pg. 1574-81
(Oct 12 2011)
ISSN: 1538-3598 [Electronic] United States |
PMID | 21976613
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
- Antioxidants
- Biomarkers
- Docosahexaenoic Acids
- gamma-Linolenic Acid
- Eicosapentaenoic Acid
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Topics |
- Acute Lung Injury
(complications, drug therapy, etiology, mortality)
- Adult
- Aged
- Antioxidants
(adverse effects, therapeutic use)
- Biomarkers
(blood)
- Dietary Supplements
(adverse effects)
- Docosahexaenoic Acids
(adverse effects, blood, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Eicosapentaenoic Acid
(adverse effects, blood, therapeutic use)
- Enteral Nutrition
- Female
- Humans
- Inflammation
(drug therapy)
- Intensive Care Units
(statistics & numerical data)
- Male
- Middle Aged
- Pneumonia
(complications)
- Sepsis
(complications)
- Survival Analysis
- Treatment Outcome
- Ventilator Weaning
- gamma-Linolenic Acid
(adverse effects, therapeutic use)
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