ARDS - EDEN OMEGA Protocol

ARDS - EDEN OMEGA 协议

• 批准号: 8270437
• 负责人: TERRI HOUGH
• 金额: $ 27.05万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8270437
• 关键词: Adult Respiratory Distress Syndrome; Albuterol; Antioxidants; Attenuated; Breathing; Calendar; Clinical; Clinical Trials Data Monitoring Committees; Dose; Enrollment; Enteral Feeding; Feeds; Futility; Hospital Mortality; Hospitals; Hour; Inflammation; Mechanical ventilation; Monitor; Morbidity - disease rate; Omega-3 Fatty Acids; Outcome; Patients; Phase; Placebos; Protocols documentation; Randomized; Randomized Controlled Clinical Trials; Research Design; Safety; Sample Size; Supplementation; Ventilator; Vital Status; base; design; feeding; gamma-Linolenic Acid; improved; mortality; patient safety; prospective; safety study

¿ Objectives: 1. To assess the safety and efficacy of initial trophic enteral feeding followed by advancement to full-calorie enteral feeding vs. initial advancement to full-calorie enteral feeding management strategies in reducing mortality and morbidity in patients with ALI or ARDS 2. To assess the safety and efficacy of omega-3 fatty acid, gamma-linolenic acid, and anti-oxidant supplementation in reducing mortality and morbidity in patients with ALI or ARDS ¿ Hypotheses: 1. Initial trophic feeding followed by full-calorie enteral feeding will improve clinical outcomes (specifically increase the number of ventilator-free days to day 28 and decrease the 60-day, hospital mortality) in patients with ALI or ARDS by reducing systemic inflammation and the number of feeding complications as compared to early, full-calorie enteral feeding. 2. Omega-3 Fatty Acid, Gamma-linolenic acid (GLA), and anti-oxidant supplementation, as compared to placebo, will improve clinical outcomes (specifically increase the number of ventilator-free days to day 28 and decrease the 60-day, hospital mortality) in patients with ALI or ARDS by attenuating systemic inflammation.

目标： 1.评估初始营养性肠内喂养随后推进至全热量肠内喂养与初始推进至全热量肠内喂养管理策略在降低ALI或ARDS患者死亡率和发病率方面的安全性和有效性 2.评估omega-3脂肪酸、γ-亚麻酸和抗氧化剂补充剂在降低ALI或ARDS患者死亡率和发病率方面的安全性和有效性 假设： 1.与早期全热量肠内喂养相比，初始营养喂养后的全热量肠内喂养将通过减少全身炎症和喂养并发症的数量来改善ALI或ARDS患者的临床结局（特别是增加至第28天的无呼吸机天数，并降低60天的住院死亡率）。 2.与安慰剂相比，Omega-3脂肪酸、γ-亚麻酸（GLA）和抗氧化剂补充剂将通过减轻全身炎症改善ALI或ARDS患者的临床结局（特别是增加至第28天的无呼吸机天数并降低60天住院死亡率）。