|A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury.|
|PMID: 21423000 Owner: NLM Status: MEDLINE|
|OBJECTIVES: Administration of eicosapentaenoic acid and docosahexanoic acid, omega-3 fatty acids in fish oil, has been associated with improved patient outcomes in acute lung injury when studied in a commercial enteral formula. However, fish oil has not been tested independently in acute lung injury. We therefore sought to determine whether enteral fish oil alone would reduce pulmonary and systemic inflammation in patients with acute lung injury.
DESIGN: Phase II randomized controlled trial.
SETTING: Five North American medical centers.
PATIENTS: Mechanically ventilated patients with acute lung injury ≥18 yrs of age.
INTERVENTIONS: Subjects were randomized to receive enteral fish oil (9.75 g eicosapentaenoic acid and 6.75 g docosahexanoic acid daily) or saline placebo for up to 14 days.
MEASUREMENTS AND MAIN RESULTS: Bronchoalveolar lavage fluid and blood were collected at baseline (day 0), day 4 ± 1, and day 8 ± 1. The primary end point was bronchoalveolar lavage fluid interleukin-8 levels. Forty-one participants received fish oil and 49 received placebo. Enteral fish oil administration was associated with increased serum eicosapentaenoic acid concentration (p < .0001). However, there was no significant difference in the change in bronchoalveolar lavage fluid interleukin-8 from baseline to day 4 (p = .37) or day 8 (p = .55) between treatment arms. There were no appreciable improvements in other bronchoalveolar lavage fluid or plasma biomarkers in the fish oil group compared with the control group. Similarly, organ failure score, ventilator-free days, intensive care unit-free days, and 60-day mortality did not differ between the groups.
CONCLUSIONS: Fish oil did not reduce biomarkers of pulmonary or systemic inflammation in patients with acute lung injury, and the results do not support the conduct of a larger clinical trial in this population with this agent. This experimental approach is feasible for proof-of-concept studies evaluating new treatments for acute lung injury.
|Renee D Stapleton; Thomas R Martin; Noel S Weiss; Joseph J Crowley; Stephanie J Gundel; Avery B Nathens; Saadia R Akhtar; John T Ruzinski; Ellen Caldwell; J Randall Curtis; Daren K Heyland; Timothy R Watkins; Polly E Parsons; Julie M Martin; Mark M Wurfel; Teal S Hallstrand; Kathryn A Sims; Margaret J Neff|
|Type: Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't|
|Title: Critical care medicine Volume: 39 ISSN: 1530-0293 ISO Abbreviation: Crit. Care Med. Publication Date: 2011 Jul|
|Created Date: 2011-06-20 Completed Date: 2011-09-26 Revised Date: 2014-09-09|
Medline Journal Info:
|Nlm Unique ID: 0355501 Medline TA: Crit Care Med Country: United States|
|Languages: eng Pagination: 1655-62 Citation Subset: AIM; IM|
|APA/MLA Format Download EndNote Download BibTex|
Acute Lung Injury
Biological Markers / analysis, blood
Body Weight / drug effects
Bronchoalveolar Lavage Fluid / chemistry*
Chemokine CCL2 / analysis
Docosahexaenoic Acids / adverse effects, blood, therapeutic use*
Drug Therapy, Combination
Eicosapentaenoic Acid / adverse effects, blood, therapeutic use*
Interleukin-6 / analysis, blood
Interleukin-8 / analysis*, blood
Leukotriene B4 / analysis, blood
Pneumonia / drug therapy
Positive-Pressure Respiration, Intrinsic
Pulmonary Surfactant-Associated Protein D / blood
Tidal Volume / drug effects
von Willebrand Factor / analysis, metabolism
|1P50HL073996/HL/NHLBI NIH HHS; 5P20RR015557/RR/NCRR NIH HHS; 8K12RR023265/RR/NCRR NIH HHS; L30 HL082146-01/HL/NHLBI NIH HHS; L30 HL082146-02/HL/NHLBI NIH HHS; L30 HL082146-03/HL/NHLBI NIH HHS; P20 RR015557/RR/NCRR NIH HHS; P20 RR015557-07/RR/NCRR NIH HHS; P50 HL073996/HL/NHLBI NIH HHS; P50 HL073996-05/HL/NHLBI NIH HHS|
|0/Biological Markers; 0/Chemokine CCL2; 0/Interleukin-6; 0/Interleukin-8; 0/Pulmonary Surfactant-Associated Protein D; 0/von Willebrand Factor; 1HGW4DR56D/Leukotriene B4; 25167-62-8/Docosahexaenoic Acids; AAN7QOV9EA/Eicosapentaenoic Acid|
Crit Care Med. 2011 Dec;39(12):2789; author reply 2789-90
Crit Care Med. 2011 Jul;39(7):1829-30 [PMID: 21685749 ]
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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