Evidence map›Paper›PMID 21423000›Full record

Trial reportCritical care medicine2011

A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of 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 and 8 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 11 pooled it
14.7field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 11 syntheses or guidelines pooled it, 172 citations in OpenAlex.

  1. Pooled it
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  4. Between-trial heterogeneity in ARDS research.Intensive care medicine · 2021
    Pooled it
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  7. Immunonutrition for acute respiratory distress syndrome (ARDS) in adults.The Cochrane database of systematic reviews · 2019
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Guideline
  12. Trial
  13. Bronchoalveolar fluid and plasma inflammatory biomarkers in contemporary ARDS patients.Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals · 2019
    Trial
  14. Trial
  15. Trial
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  19. Heterogeneous Causes of Acute Respiratory Distress Syndrome Correlate With Distinct Peripheral Polyunsaturated Fatty Acid Metabolites.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 2 countries.

Renee D StapletonDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, University of Vermont College of Medicine, Burlington, VT, USA. renee.stapleton@uvm.edu
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
University of Washington · USUniversity of Vermont · USBloodworks Northwest · USCancerCare · USQueen's University · CASt. Luke’s Boise Medical Center · USUniversity of Toronto · CA

Funding

WEIGHT LOSS & ASTHMAP20RR015557 · NCRR · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI IRVIN, CHARLES G · 2000 to 2009
$21.4M
SCCOR in Translational Research in Acute Lung InjuryP50HL073996 · NHLBI · UNIVERSITY OF WASHINGTON · PI HUDSON, LEONARD D · 2003 to 2007
$15.7M
UW Multidisciplinary Clinical Research Training (RMI)K12RR023265 · NCRR · UNIVERSITY OF WASHINGTON · PI PROBSTFIELD, JEFFREY LYNN · 2005 to 2007
$6.1M
NCRR NIH HHS 5P20RR015557NCRR NIH HHS 8K12RR023265NCRR NIH HHS K12 RR023265NCRR NIH HHS P20 RR015557NHLBI NIH HHS 1P50HL073996NHLBI NIH HHS L30 HL082146NHLBI NIH HHS P50 HL073996
6 · The paper itself

Abstract

objectivesAdministration 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.

designPhase II randomized controlled trial.

settingFive North American medical centers. PATIENTS: Mechanically ventilated patients with acute lung injury ≥18 yrs of age.

interventionsSubjects 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

resultsBronchoalveolar 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.

conclusionsFish 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.

Indexed as

Enteral NutritionAcute Lung InjuryAdultAgedBiomarkersBody WeightBronchoalveolar Lavage FluidCell CountChemokine CCL2Docosahexaenoic AcidsDrug Therapy, CombinationEicosapentaenoic AcidFemaleHospital MortalityHumansInterleukin-6BiomarkersChemokine CCL2Docosahexaenoic AcidsEicosapentaenoic AcidInterleukin-6Interleukin-8Leukotriene B4Pulmonary Surfactant-Associated Protein Dvon Willebrand Factor

Identifiers

PMID21423000
PMCPMC3125670
OpenAlexW1964899513

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.