Critical care medicine · 2011
A phase II randomized placebo-controlled trial of omega-3 fatty acids for the treatment of acute lung injury.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
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
Аннотация
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.
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.
Предметные рубрики MeSH
Acute Lung InjuryAdultAgedBiomarkersBody WeightBronchoalveolar Lavage FluidCell CountChemokine CCL2Docosahexaenoic AcidsDrug Therapy, CombinationEicosapentaenoic AcidEnteral NutritionFemaleHospital MortalityHumansInterleukin-6Interleukin-8Leukotriene B4MaleMiddle AgedNeutrophilsPneumoniaPositive-Pressure Respiration, IntrinsicPulmonary Surfactant-Associated Protein DTidal Volumevon Willebrand Factor