Enteral omega-3 fatty acid, gamma-linolenic acid, and antioxidant supplementation in acute lung injury
Rice TW, Wheeler AP, Thompson BT, deBoisblanc BP, Steingrub J, Rock P, NIH NHLBI Acute Respiratory Distress Syndrome Network of Investigators, NHLBI ARDS Clinical Trials Network
JAMA · 362 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
- U.S. Public Health Service
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- NHLBI NIH HHS
- Gobierno
- PHS HHS
- Subvenciones
- National Heart, Lung, and Blood Institute (N01 HR056166); National Heart, Lung, and Blood Institute (N01 HR056167); National Heart, Lung, and Blood Institute (N01 HR056165); National Heart, Lung, and Blood Institute (N01 HR056169); U.S. Public Health Service (HHSN 268200536179C); National Heart, Lung, and Blood Institute (N01 HR056172); National Heart, Lung, and Blood Institute (N01 HR056171); National Heart, Lung, and Blood Institute (N01 HR056168); National Heart, Lung, and Blood Institute (N01 HR056175); U.S. Public Health Service (HHSN268200536165C); National Heart, Lung, and Blood Institute (N01 HR056170); National Heart, Lung, and Blood Institute (N01 HR056173); National Heart, Lung, and Blood Institute (N01 HR056176); U.S. Public Health Service (HHSN268200536176C); National Heart, Lung, and Blood Institute (N01 HR056179); National Heart, Lung, and Blood Institute (N01 HR056174)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2011-10-06 · JAMA · vol. 306 · número 14 · pág. 1574
- Editorial
- American Medical Association
- Citado
- 551 citas · más que el 100% de estudios similares · 43.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 29 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Clinical Nutrition and Gastroenterology · Respiratory Support and Mechanisms · Fatty Acid Research and Health
- Palabras clave
- acute lung injury, omega-3 fatty acids, docosahexaenoic acid, eicosapentaenoic acid, gamma-linolenic acid, antioxidants, enteral nutrition, dietary supplementation, ventilator-free days, mechanical ventilation, organ failure, mortality, acute respiratory distress syndrome, systemic inflammatory response, futility, diarrhea
- MeSH
- humans, sepsis, pneumonia, inflammation, docosahexaenoic acids, eicosapentaenoic acid, gamma-linolenic acid, antioxidants, treatment outcome, drug therapy, combination, enteral nutrition, ventilator weaning, survival analysis, double-blind method, dietary supplements, adult, aged, middle aged, intensive care units, female, male, acute lung injury, biomarkers
1 autor
- Todd W. Rice🇺🇸 · autor de correspondenciaVanderbilt University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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