Randomized, Placebo Controlled Trial of the Effectiveness of Statins for Preventing Mortality Following ICU Admission for Influenza Complications
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 21
- 主要终点
- Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).
研究概览
简要总结
To assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (ICU) admission due to respiratory distress.
详细描述
Hypothesis
Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected or confirmed influenza (Appendix A)
- •Requirement for ICU (or ICU step-down) admission due to respiratory distress defined as:
- •SaO2/FiO2 < 315 or PaO2/FiO2 < 300
- •Multiply by PB/760 (when altitude exceeds 51000 ft)
- •For FiO2 for non-intubated patients see Appendix B
- •Participants must receive the first dose of study drug within 48 hours following ICU admission for confirmed or suspected influenza or be excluded from participation in the study.
排除标准
- •No consent/inability to obtain consent
- •Age less than 13 years
- •Weight less than 40 kg
- •Unable to receive or unlikely to absorb enteral study drug (e.g. patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome)
- •Allergy or intolerance to statins*
- •Pregnancy or breast feeding
- •Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, or any antiviral protease inhibitor including but not limited to lopinavir and ritonavir.
- •Existing clinically significant myositis or myopathy or has a measured CK greater than 5,000 U/L
- •Requiring statin for underlying disease as determined by the patients attending physician team**.
- •Severe chronic liver disease (Child-Pugh Score 11-15)
- •Previous myocardial infarction or thrombotic stroke within the past 6 months 11.
- •Any significant funding in the patient's medical history or physical or psychiatric exam prior to randomization that, in the opinion of the investigator, would affect patient safety or compliance or ability to deliver the study drug according to protocol
研究组 & 干预措施
Placebo tablet
Placebo
干预措施: Placebo (Drug)
Rosuvastatin (crestor)
Experimental arm
干预措施: Rosuvastatin (crestor) (Drug)
结局指标
主要结局
Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).
时间窗: 28 days
No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of \>2000 participants planned/anticipated actually enrolled.
次要结局
未报告次要终点
研究者
Gordon Bernard
Professor of Medicine
Vanderbilt University Medical Center