ARDS - SAILS Protocol

ARDS - SAILS 协议

• 批准号: 8429040
• 负责人: Roy G. Brower
• 金额: $ 15.67万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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 2012-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8429040
• 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; 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.

他汀类药物因脓毒症（帆）方案急性损伤肺的目的是评估口服美伐伐汀在脓毒症引起的急性肺损伤（ALI）患者中的疗效和安全性。 在研究设计中，最多将有1000名ALI患者随机分组。第一个研究药物剂量（rosuvastatin或安慰剂）为40 mg。随后的20 mg剂量将每天服用，直到随机分组后的28天或ICU出院后的三天（以先到者为准）或从学习医院出院。该研究假设是沙特妇蛋白将降低死亡率的主要功效变量是研究第60天的死亡率。