A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury
Stapleton RD, Martin TR, Weiss NS, Crowley JJ, Gundel SJ, Nathens AB, Akhtar SR, Ruzinski JT, Caldwell E, Curtis JR, Heyland DK, Watkins TR, Parsons PE, Martin JM, Wurfel MM, Hallstrand TS, Sims KA, Neff MJ
Critical care medicine · 103 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Center for Research Resources
- Gobierno
- NCRR NIH HHS
- Gobierno
- NHLBI NIH HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (L30 HL082146); National Heart, Lung, and Blood Institute (P50-HL073996); National Center for Research Resources (P20 RR015557); National Center for Research Resources (5P20RR015557); National Heart, Lung, and Blood Institute (1P50HL073996); National Center for Research Resources (8K12RR023265); National Center for Research Resources (K12-RR023265)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2011-03-19 · Crit Care Med · vol. 39 · número 7 · págs. 1655–1662
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 173 citas · más que el 99% de estudios similares · 14.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 60 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Respiratory Support and Mechanisms · Clinical Nutrition and Gastroenterology · Fatty Acid Research and Health
- Palabras clave
- 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
- neutrophils, bronchoalveolar lavage fluid, humans, pneumonia, positive-pressure respiration, intrinsic, body weight, docosahexaenoic acids, eicosapentaenoic acid, leukotriene b4, von willebrand factor, pulmonary surfactant-associated protein d, interleukin-8, interleukin-6, tidal volume, drug therapy, combination, enteral nutrition, cell count, hospital mortality, adult, aged, middle aged, female, male, chemokine ccl2, acute lung injury, biomarkers
18 autores
- Renee D. Stapleton🇺🇸University of Vermont; University of Vermont Medical Center
- Thomas R. Martin🇺🇸University of Washington
- Noel S. Weiss🇺🇸University of Washington
- Joseph J. Crowley
- Stephanie J. Gundel🇺🇸University of Washington
- Avery B. Nathens🇨🇦University of Toronto
- Saadia R. Akhtar🇺🇸St. Luke’s Boise Medical Center
- JOHN T. RUZINSKI🇺🇸University of Washington
- Ellen Caldwell🇺🇸University of Washington
- Jared Randall Curtis🇺🇸University of Washington
- Daren Keith Heyland🇨🇦Queen's University
- Timothy R. Watkins🇺🇸Bloodworks Northwest
- Polly E. Parsons🇺🇸University of Vermont
- Julie Martin🇺🇸University of Vermont
- Mark M. Wurfel🇺🇸University of Washington
- Teal S. Hallstrand🇺🇸University of Washington
- Kathryn A. Sims🇺🇸University of Washington
- Margaret J. Neff🇺🇸University of Washington
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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