ARDS - SAILS Protocol

ARDS - SAILS 协议

• 批准号: 8429044
• 负责人: NEIL R MACINTYRE
• 金额: $ 40.6万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-12-01 至 2012-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8429044
• 关键词: Acute; Acute Lung Injury; Adult Respiratory Distress Syndrome; Dose; Hospitals; Lung; Oral; Patients; Pharmaceutical Preparations; Placebos; Protocols documentation; Randomized; Research Design; Safety; Sepsis; injured; lung injury; 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急性肺损伤(SAILS)方案的目的是评价口服瑞舒伐他汀治疗脓毒症所致急性肺损伤(ALI)的疗效和安全性。 在研究设计中，多达1000名ALI患者将被随机分组。第一项研究的药物剂量(瑞舒伐他汀或安慰剂)为40毫克。随后的20毫克剂量将每天给予，直到随机分组后28天或ICU出院后3天(以先发生的为准)，或从研究医院出院。研究假设为瑞舒伐他汀可降低死亡率，主要疗效变量为研究第60天的死亡率。