| Enteral omega-3 fatty acid, gamma-linolenic acid, and antioxidant supplementation in acute lung injury. | |
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MedLine Citation:
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PMID: 21976613 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Todd W Rice; Arthur P Wheeler; B Taylor Thompson; Bennett P deBoisblanc; Jay Steingrub; Peter Rock; ; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural Date: 2011-10-05 |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 306 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2011 Oct |
Date Detail:
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Created Date: 2011-10-12 Completed Date: 2011-10-13 Revised Date: 2012-02-21 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 1574-81 Citation Subset: AIM; IM |
Affiliation:
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Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA. todd.rice@vanderbilt.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00609180 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acute Lung Injury
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complications,
drug therapy*,
etiology,
mortality Adult Aged Antioxidants / adverse effects, therapeutic use* Biological Markers / 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 / utilization Male Middle Aged Pneumonia / complications Sepsis / complications Survival Analysis Treatment Outcome Ventilator Weaning* gamma-Linolenic Acid / adverse effects, therapeutic use* |
| Grant Support | |
ID/Acronym/Agency:
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HHSN268200536165C//PHS HHS; HHSN268200536176C//PHS HHS; HHSN268200536179C//PHS HHS |
| Chemical | |
Reg. No./Substance:
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0/Antioxidants; 0/Biological Markers; 1553-41-9/Eicosapentaenoic Acid; 25167-62-8/Docosahexaenoic Acids; 506-26-3/gamma-Linolenic Acid |
| Investigator | |
Investigator/Affiliation:
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L Hudson / ; C Hough / ; M Neff / ; K Sims / ; T Watkins / ; J Steingrub / ; M Tidswell / ; L DeSouza / ; C Kardos / ; L Kozikowski / ; K Kozikowski / ; K Guntupalli / ; V Bandi / ; C Pope / ; R Brower / ; H Fessler / ; D Hager / ; P Mendez-Tellez / ; K Oakjones / ; D Needham / ; J Sevransky / ; A Workneh / ; S Han / ; S Murray / ; C Shanholtz / ; G Netzer / ; P Rock / ; A Sampaio / ; J Titus / ; P Sloane / ; T Beck / ; H Highfield / ; D Herr / ; B Lee / ; N Bolouri / ; H P Wiedemann / ; R W Ashton / ; D A Culver / ; T Frederick / ; J J Komara / ; J A Guzman / ; A J Reddy / ; R Hejal / ; M Andrews / ; D Haney / ; A F Connors / ; S Lasalvia / ; J D Thornton / ; E L Warren / ; M Moss / ; A Benson / ; E Burnham / ; B Clark / ; L Gray / ; C Higgins / ; B J Maloney / ; M Mealer / ; S Frankel / ; T Bost / ; P Dennen / ; K Hodgin / ; I Douglas / ; K Overdier / ; K Thompson / ; R Wolken / ; N MacIntyre / ; L Brown / ; C Cox / ; M Gentile / ; J Govert / ; N Knudsen / ; S Carson / ; L Chang / ; J Lanier / ; A P Wheeler / ; G R Bernard / ; M Hays / ; S Mogan / ; T W Rice / ; R D Hite / ; P E Morris / ; A Harvey / ; M Ragusky / ; K Bender / ; P Wright / ; S Gross / ; J McLean / ; A Overton / ; J Truwit / ; K Enfield / ; M Marshall / ; T Clemmer / ; R Tanaka / ; L Weaver / ; A Morris / ; A Ahmed / ; A Austin / ; N Dean / ; C Grissom / ; A Fitzpatrick / ; E Hirshberg / ; N Kumar / ; R Miller / ; J Orme / ; S Pandita / ; G Schreiber / ; L Struck / ; F Thomas / ; G Thomsen / ; D VanBoerum / ; T White / ; M Zenger / ; D Dienhart / ; P Nelson / ; M Goddard / ; J Krueger / ; L Napoli / ; C Lawton / ; J Baughman / ; T Fujii / ; D Hanselman / ; T Hoffman / ; B Kerwin / ; P Kim / ; F Leung / ; K Sundar / ; W Alward / ; E Campbell / ; D Eckley / ; T Hill / ; K Ludwig / ; D Nielsen / ; M Pearce / ; M A Matthay / ; C Calfee / ; B Daniel / ; M Eisner / ; O Garcia / ; E Johnson / ; R Kallet / ; K Kordesch / ; K Liu / ; H Zhou / ; M W Peterson / ; J Blaauw / ; T Albertson / ; E Vlastelin / ; R Hubmayr / ; D Brown / ; O Gajic / ; R Hinds / ; S Holets / ; D J Kor / ; M Passe / ; B deBoisblanc / ; P Lauto / ; C Romaine / ; G Meyaski / ; J Hunt / ; A Marr / ; S Brierre / ; C LeBlanc / ; D Taylor / ; S Jain / ; L Seoane / ; F Simeone / ; J Fearon / ; J Duchesne / ; D Schoenfeld / ; M Aquino / ; N Dong / ; D Dorer / ; M Guha / ; E Hammond / ; N Lavery / ; P Lazar / ; I Molina / ; R Morse / ; C Oldmixon / ; B Rawal / ; N Ringwood / ; A Shui / ; E Smoot / ; B T Thompson / ; A Harabin / ; S Bredow / ; M Waclawiw / ; G Weinmann / ; R G Spragg / ; A Slutsky / ; M Levy / ; B Markovitz / ; E Petkova / ; C Weijer / ; J Sznajder / ; M Begg / ; E Israel / ; J Lewis / ; S McClave / ; P Parsons / |
| Comments/Corrections | |
Comment In:
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JAMA. 2012 Jan 11;307(2):144; author reply 145-6
[PMID:
22235078
]
JAMA. 2011 Oct 12;306(14):1599-600 [PMID: 21976612 ] JAMA. 2012 Jan 11;307(2):145; author reply 145-6 [PMID: 22235080 ] JAMA. 2012 Jan 11;307(2):144-5; author reply 145-6 [PMID: 22235079 ] |
Erratum In:
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JAMA. 2012 Feb 8;307(6):563 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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