A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury*

Stapleton, Renee D.; Martin, Thomas R.; Weiss, Noel S.; Crowley, Joseph J.; Gundel, Stephanie J.; Nathens, Avery B.; Akhtar, Saadia R.; Ruzinski, John T.; Caldwell, Ellen; Curtis, J. Randall; Heyland, Daren K.; Watkins, Timothy R.; Parsons, Polly E.; Martin, Julie M.; Wurfel, Mark M.; Hallstrand, Teal S.; Sims, Kathryn A.; Neff, Margaret J.

doi:10.1097/ccm.0b013e318218669d

Cited by 173Respiratory Support and MechanismsClinical Nutrition and GastroenterologyFatty Acid Research and Health

A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury*

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Stapleton, Renee D., Martin, Thomas R., Weiss, Noel S., Crowley, Joseph J., Gundel, Stephanie J., Nathens, Avery B., Akhtar, Saadia R., Ruzinski, John T. +10 more·2011·Critical Care Medicine

DOI 10.1097/ccm.0b013e318218669dPMC PMC3125670

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Abstract

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.

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Enteral formulae enriched in borage oil and/or omega-3 fatty acids have been administered in patients suffering from ARDS, acute lung injury and sepsis with positive effects regarding length of stay, length of ventilation and even mortality.
“Enteral formulae enriched in borage oil and/or omega-3 FA have been administered in patients suffering from ARDS, acute lung injury (ALI) and sepsis with positive effects regarding length of stay, length of ventilation and even mortality (239,240,245,248).”
From ESPEN guideline on clinical nutrition in the intensive care unit. (2019) · cites this paper as [239]
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[57]The NHLBI ARDS Network Trial of omega-3 fatty acid, gamma-linolenic acid and antioxidant supplemention in the management of acute lung injury (OMEGA) Results presented at: American Thoracic Society International Conference May, 18, 2009 San Diego, California

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Authors: Stapleton, R. D., Martin, T. R., Weiss, N. S., Crowley, J. J., Gundel, S. J., Nathens, A. B., Akhtar, S. R., Ruzinski, J. T., Caldwell, E., Curtis, J. R., Heyland, D. K., Watkins, T. R., Parsons, P. E., Martin, J. M., Wurfel, M. M., Hallstrand, T. S., Sims, K. A., & Neff, M. J.
Affiliations: University of Vermont (US)
University of Washington (US)
Saint Alphonsus Regional Medical Center (US)
University of Toronto (CA)
St. Luke’s Boise Medical Center (US)
Queen's University (CA)
ORCID: Martin, Thomas R.
Weiss, Noel S.
Nathens, Avery B.
Akhtar, Saadia R.
Caldwell, Ellen
Curtis, J. Randall
Heyland, Daren K.
Martin, Julie M.
Hallstrand, Teal S.
Venue: Critical Care Medicine
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2011-07
Volume: 39
Issue: 7
Pages: 1655-1662
ISSN: 0090-3493 (ISSN-L)
DOI: 10.1097/ccm.0b013e318218669d
PMC: PMC3125670
OpenAlex: W1964899513
Cited by: 173
References: 60
Citations by year: 2026: 6 · 2025: 4 · 2024: 1 · 2023: 8 · 2022: 16 · 2021: 10 · 2020: 9 · 2019: 9 · 2018: 9 · 2017: 11 · 2016: 11 · 2015: 19 · 2014: 22 · 2013: 15 · 2012: 15
FWCI: 16.08
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Critical Care Medicine (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (5k12rr023265-03)
National Heart, Lung, and Blood Institute (P50HL073996, L30 HL082146)
National Center for Research Resources (P20RR015557, 8K12RR023265, K12-RR023265)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
Keywords: acute lung injury, omega-3 fatty acids, fish oil, eicosapentaenoic acid, docosahexaenoic acid, enteral nutrition, mechanical ventilation, interleukin-8, bronchoalveolar lavage fluid, lung inflammation, systemic inflammation, biomarkers, mortality
MeSH terms: Adult, Aged, Body Weight, Bronchoalveolar Lavage Fluid, Cell Count, Docosahexaenoic Acids, Drug Therapy, Combination, Enteral Nutrition, Female, Humans, Leukotriene B4, Male, Middle Aged, Neutrophils, Pneumonia, Tidal Volume, von Willebrand Factor, Eicosapentaenoic Acid, Biomarkers, Interleukin-6, Interleukin-8, Hospital Mortality, Positive-Pressure Respiration, Intrinsic, Chemokine CCL2, Pulmonary Surfactant-Associated Protein D, Acute Lung Injury

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A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury*

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