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。评估初始营养肠内喂养的安全性和效率，然后进步到全卡路里肠内喂养与最初的进步与最初的进步，以降低ALI或ARDS患者的全卡路里肠内喂养管理策略，以降低死亡率和发病率 2。评估omega-3脂肪酸，γ-亚麻酸的安全性和效率，以及降低ALI或ARDS患者的死亡率和发病率的抗氧化剂补充剂 假设： 1。最初的营养喂养，然后是全卡路里肠内喂养将改善临床结果（特别增加了ALI或ARDS患者的60天的无通风天数，并降低了60天的医院死亡率），通过减少系统性注射和与早期的喂养并发症的数量相比，全身注射的次数减少了全身注射的数量。 2。与安慰剂相比，Omega-3脂肪酸，γ-中苯甲酸（GLA）和抗氧化剂补充剂将改善临床结局（特别是在28天到第28天的无通风剂天数，并减少60天，医院死亡率），患有ALI或ARDS的患者通过衰减系统性炎症。