Evidence map›Paper›PMID 21976613›Full record

Trial reportJAMA2011

Enteral omega-3 fatty acid, gamma-linolenic acid, and antioxidant supplementation in acute lung injury.

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

Erratum issued Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00609180 (Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury), which is not on this map. Cited by 223 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
223citing papers in PubMed, 21 pooled it
41.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00609180 phase3terminatednot on this map

Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and Prospective, Randomized, Blinded, Placebo-Controlled, Multi-Center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2007 to 2009Enrolled272ConditionsRespiratory Distress Syndrome, AdultArmsMinimal (Trophic) Feeding, Full Feeding, Omega-3 Fatty Acids and Antioxidant Supplements, Placebo
3 · Its place in the literature

Who cites it

223 citing papers in PubMed, 21 syntheses or guidelines pooled it, 537 citations in OpenAlex.

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  8. Between-trial heterogeneity in ARDS research.Intensive care medicine · 2021
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  10. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
    Guideline
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  12. Immunonutrition for acute respiratory distress syndrome (ARDS) in adults.The Cochrane database of systematic reviews · 2019
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  13. Guideline
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  17. Brazilian recommendations of mechanical ventilation 2013. Part 2.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2014
    Guideline
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  20. Guideline

163 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Todd W RiceDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee, USA. todd.rice@vanderbilt.edu
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
Vanderbilt University · US

Funding

Lung Surfactant Activity, Inhibition and ReplacementR01HL056176 · NHLBI · UNIVERSITY OF ROCHESTER · PI NOTTER, ROBERT H · 1997 to 2006
$1.8M
Ferritin and Iron Nutrition in Health and DiseaseR01HL056169 · NHLBI · CHILDREN'S HOSPITAL &RES CTR AT OAKLAND · PI THEIL, ELIZABETH C · 1998 to 2005
$1.6M
Clin Coord Ctr for Clin Ntwrk Treatment of ARDS-268056179-268056179N01HR056179 · HR · MASSACHUSETTS GENERAL HOSPITAL · PI SCHOENFELD, DAVID · 2005 to 2006
–
NHLBI NIH HHS N01 HR056165NHLBI NIH HHS N01 HR056166NHLBI NIH HHS N01 HR056167NHLBI NIH HHS N01 HR056168NHLBI NIH HHS N01 HR056169NHLBI NIH HHS N01 HR056170NHLBI NIH HHS N01 HR056171NHLBI NIH HHS N01 HR056172NHLBI NIH HHS N01 HR056173NHLBI NIH HHS N01 HR056174NHLBI NIH HHS N01 HR056175NHLBI NIH HHS N01 HR056176NHLBI NIH HHS N01 HR056179PHS HHS HHSN268200536165CPHS HHS HHSN268200536176CPHS HHS HHSN268200536179C
6 · The paper itself

Abstract

contextThe 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.

objectiveTo 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

participantsThe 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.

interventionsTwice-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 measureVentilator-free days to study day 28.

resultsThe 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).

conclusionsTwice-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 registrationclinicaltrials.gov Identifier: NCT00609180.

Indexed as

Ventilator WeaningAcute Lung InjuryAdultAgedAntioxidantsBiomarkersDietary SupplementsDocosahexaenoic AcidsDouble-Blind MethodDrug Therapy, CombinationEicosapentaenoic AcidEnteral NutritionFemalegamma-Linolenic AcidHumansInflammationAntioxidantsBiomarkersDocosahexaenoic AcidsEicosapentaenoic Acidgamma-Linolenic Acid

Identifiers

PMID21976613
PMCPMC3770348
OpenAlexW2121517569

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.