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ARDS - SAILS Protocol

ARDS - SAILS Protocol
ARDS - SAILS 协议
批准号：
8429057
负责人：
MICHAEL A. MATTHAY
金额：
$42.75万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
项目状态：
已结题
起止时间：
2005-09-30 至 2012-10-31
来源：
https://reporter.nih.gov/project-details/8429057
关键词：
Acute Lung InjuryAdult Respiratory Distress SyndromeDoseHospitalsLungOralPatientsPharmaceutical PreparationsPlacebosProtocols documentationRandomizedResearch DesignSafetySepsisinjuredmortalityrosuvastatin

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英文摘要
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.
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