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REVISE:重新评估ICU统计分析计划中的应力侵蚀抑制,用于随机试验

Diane Heels-Ansdell¹, Laurent Billot², Lehana Thabane¹

¹Department of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.

|December 7, 2023

概括

该REVISE试验调查了潘托普拉与安慰剂对机械通风ICU患者的压力的预防. 结果将指导临床实践对重症患者.

科学领域:

关键护理医学关键护理医学
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

该REVISE试验评估了潘托普拉在预防机械通风ICU患者的压力侵蚀方面的疗效.
质子抑制剂是常用的,但它们在这个人群中的益处需要严格的评估.

研究的目的:

详细说明REVISE随机临床试验的统计分析计划.
确保对潘托普拉对重症患者的影响进行可靠和透明的评估.

主要方法:

一个随机临床试验,涉及成年,侵入性通风ICU患者.
患者接受静脉注射的潘托普拉 (40毫克) 或安慰剂.
该试验是在国际范围内进行的,目标样本大小为4800名患者.

主要成果:

主要疗效终点是临床显著的上部胃肠道出血.
关键的安全结果包括90天死亡率和呼吸机相关的肺炎.
对2400名患者的临时分析支持继续进行试验.

结论:

统计分析计划涵盖所有初级,二级和三级结果.
敏感性和子组分析将提供全面的见解.
预计这些发现将影响临床实践和ICU患者护理指南.

关键词:

克洛斯特里迪奥伊德困难感染.病情危急,病情危急.胃肠道出血胃肠道出血压力性的形成与呼吸机相关的肺炎.

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