Giuseppe
Emeritus
[Source: JAMA, full text: (LINK). Abstract, edited.]
ONLINE FIRST
<CITE><ABBR>JAMA.</ABBR> 2011;306(14):1574-1581. Published online October 5, 2011.doi: 10.1001/jama.2011.1435</CITE>
Enteral Omega-3 Fatty Acid, γ-Linolenic Acid, and Antioxidant Supplementation in Acute Lung Injury
Todd W. Rice, MD, MSc; Arthur P. Wheeler, MD; B. Taylor Thompson, MD; Bennett P. deBoisblanc, MD; Jay Steingrub, MD; Peter Rock, MD, MBA for the NHLBI ARDS Clinical Trials Network
Author Affiliations:
Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee (Drs Rice and Wheeler); Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Boston (Dr Thompson); Pulmonary and Critical Care Medicine, Louisiana State University Health Sciences Center, New Orleans (Dr deBoisblanc); Critical Care Medicine, Baystate Medical Center, Springfield, Massachusetts (Dr Steingrub); and Department of Anesthesiology, University of Maryland School of Medicine, Baltimore (Dr Rock).
Abstract
Context
The omega-3 (n-3) fatty acids docosahexaenoic acid and eicosapentaenoic acid, along with γ-linolenic acid and antioxidants, may modulate systemic inflammatory response and improve oxygenation and outcomes in patients with acute lung injury.
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
Twice-daily enteral supplementation of n-3 fatty acids, γ-linolenic acid, and antioxidants compared with an isocaloric control. Enteral nutrition, directed by a protocol, was delivered separately from the study supplement.
Main Outcome Measure
Ventilator-free days to study day 28.
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
Twice-daily enteral supplementation of n-3 fatty acids, γ-linolenic acid, and antioxidants did not improve the primary end point of ventilator-free days or other clinical outcomes in patients with acute lung injury and may be harmful.
Trial Registration
clinicaltrials.gov Identifier: NCT00609180
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ONLINE FIRST
<CITE><ABBR>JAMA.</ABBR> 2011;306(14):1574-1581. Published online October 5, 2011.doi: 10.1001/jama.2011.1435</CITE>
Enteral Omega-3 Fatty Acid, γ-Linolenic Acid, and Antioxidant Supplementation in Acute Lung Injury
Todd W. Rice, MD, MSc; Arthur P. Wheeler, MD; B. Taylor Thompson, MD; Bennett P. deBoisblanc, MD; Jay Steingrub, MD; Peter Rock, MD, MBA for the NHLBI ARDS Clinical Trials Network
Author Affiliations:
Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee (Drs Rice and Wheeler); Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Boston (Dr Thompson); Pulmonary and Critical Care Medicine, Louisiana State University Health Sciences Center, New Orleans (Dr deBoisblanc); Critical Care Medicine, Baystate Medical Center, Springfield, Massachusetts (Dr Steingrub); and Department of Anesthesiology, University of Maryland School of Medicine, Baltimore (Dr Rock).
Abstract
Context
The omega-3 (n-3) fatty acids docosahexaenoic acid and eicosapentaenoic acid, along with γ-linolenic acid and antioxidants, may modulate systemic inflammatory response and improve oxygenation and outcomes in patients with acute lung injury.
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
Twice-daily enteral supplementation of n-3 fatty acids, γ-linolenic acid, and antioxidants compared with an isocaloric control. Enteral nutrition, directed by a protocol, was delivered separately from the study supplement.
Main Outcome Measure
Ventilator-free days to study day 28.
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
Twice-daily enteral supplementation of n-3 fatty acids, γ-linolenic acid, and antioxidants did not improve the primary end point of ventilator-free days or other clinical outcomes in patients with acute lung injury and may be harmful.
Trial Registration
clinicaltrials.gov Identifier: NCT00609180
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