ARDS - SAILS Protocol

ARDS - SAILS 协议

• 批准号: 8602426
• 负责人: Rolf D Hubmayr
• 金额: $ 4.56万
• 依托单位: MAYO CLINIC ROCHESTER
• 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 2013-07-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8602426
• 关键词: Acute Lung Injury; Adult Respiratory Distress Syndrome; Dose; Hospitals; Lung; Oral; Patients; Pharmaceutical Preparations; Placebos; Protocols documentation; Randomized; Research Design; Safety; Sepsis; injured; mortality; rosuvastatin

The purpose of the Statins for Acutely Injured Lungs from Sepsis (SAILS) protocol is to assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI). Up to 1000 patients with ALI will be randomized in the study design. The first study drug dose (rosuvastatin or placebo) is 40 mg. Subsequent doses of 20 mg will be administered daily until 28 days after randomization or three days after ICU discharge (whichever occurs first), or discharge from study hospital. The study hypothesis is that the Rosuvastatin will reduce mortality The primary efficacy variable is mortality to study day 60.

他汀类药物治疗脓毒症所致急性肺损伤（SAILS）方案的目的是评估口服瑞舒伐他汀在脓毒症诱导的急性肺损伤（ALI）患者中的疗效和安全性。 在研究设计中，将随机分配多达1000例ALI患者。首剂研究药物（瑞舒伐他汀或安慰剂）为40 mg。后续剂量为20 mg，每日给药一次，直至随机化后28天或ICU出院后3天（以先发生者为准）或从研究医院出院。研究假设是瑞舒伐他汀将降低死亡率。主要疗效变量是研究第60天的死亡率。