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

Abstract

Objectives Administration of eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), omega-3 fatty acids in fish oil, has been associated with improved patient outcomes in acute lung injury (ALI) when studied in a commercial enteral formula. However, fish oil has not been tested independently in ALI. We therefore sought to determine if enteral fish oil alone would reduce pulmonary and systemic inflammation in patients with ALI. Design Phase II randomized controlled trial. Setting Four North American medical centers. Patients Mechanically ventilated patients with ALI ≥ 18 years of age. Interventions Subjects were randomized to receive enteral fish oil (9.75g EPA and 6.75g DHA daily) or saline placebo for up to 14 days. Measurements and Main Results Bronchoalveolar lavage fluid (BALF) and blood were collected at baseline (day 0), day 4±1, and day 8±1. The primary endpoint was BALF interleukin (IL)-8 levels. Forty-one participants received fish oil and 49 received placebo. Enteral fish oil administration was associated with increased serum EPA concentration (p<0.0001). However, there was no significant difference in the change in BALF IL-8 from baseline to day 4 (p=0.37) or day 8 (p=0.55) between treatment arms. There were no appreciable improvements in other BALF or plasma biomarkers in the fish oil group compared to the control group. Similarly, organ failure score, ventilator-free days, ICU-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 ALI, 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 ALI.

Salvianolic acid B attenuates lipopolysaccharide-induced acute lung injury in rats through inhibition of apoptosis, oxidative stress and inflammation

“…In the clinic, affected patients present with intractable hypoxemia and progressive respiratory distress. The major associatedpathologic changes are extensive injury of pulmonary capillary endothelial cells and alveolar epithelial cells (2). Subsequently, pneumonedema develops and the membrane becomes transparent (3).…”

Enteral Nutrition After Advadvanced Combined Operative Interventions in Oncosurgery

“…Были проведены исследова-ния данного энтерального питания у больных с острым повреждением легких или острым респираторным дис-тресс-синдромом (ОПЛ/ОРДС). Данные рандомизиро-ванных исследований и метаанализов противоречивы [14,[15][16][17][18][19]. ■ Одно из исследований включало 272 пациента с ОПЛ/ ОРДС, находившихся на ИВЛ, которым назначали либо эн-теральное питание с добавлением омега-3 жирных кис-лот плюс антиоксиданты, либо стандартное энтеральное питание [17].…”

“…Кроме того, существовала тенденция к увеличению смертности (27 против 16%). В единственном исследовании стандарт-ной формулы энтерального питания и с добавкой толь-ко омега-3 жирных кислот (без каких-либо антиоксидан-тов) не было выявлено никаких различий в концентрации воспалительных маркеров, длительности искусственной вентиляции легких или смертности [18]. ■ В отличие от этого более раннее исследование вклю-чало 146 пациентов с ОПЛ/ОРДС, получавших либо эн-теральное питание с добавлением антиоксидантов плюс омега-3 ЖК, либо контрольное энтеральное питание [16].…”

Hospital Based Nutrition Support: A Review of the Latest Evidence

“…The OMEGA trial evaluated the role of omega fatty acid supplementation in acute lung injury (ALI) and was stopped early due to lack of efficacy [72]. Another phase II trial evaluated FO (high in omega-3) supplementation in patients with ALI and failed to show a benefit in physiologic or clinical endpoints [73]. The results of these studies are summarized in (Table 4).…”