富罗塞米德与安慰剂对重症监护患者的液体过载-随机GODIF试验第二版:统计分析计划
Sine Wichmann1, Theis Lange2, Anders Perner3,4
1Department of Anaesthesia and Intensive Care, Copenhagen University Hospital-North Zealand, Hilleroed, Denmark.
Acta anaesthesiologica Scandinavica
|September 11, 2023
概括
在重症监护室 (ICU) 患者的液体过载增加了死亡率. 在GODIF试验中,研究的是,与安慰剂相比,西米德 (furosemide) 是否能改善这些重症患者的治疗结果.
科学领域:
- 关键护理医学 关键护理医学
- 腎臟病學 (nephrology) 是一種醫學專業.
- 临床试验方法论 临床试验方法论
背景情况:
- 液体过载是重症监护室 (ICU) 患者死亡率增加的重要危险因素.
- 在重症患者中,有效的液体清除策略仍然是一个关键的临床挑战.
- 该GODIF试验解决了对中度至重度流体过载的流体管理的证据需求.
研究的目的:
- 详细说明GODIF试验主要结果的统计分析计划 (第二版).
- 评估使用罗塞米德去除液体的益处和危害,与安慰剂相比.
- 评估液体除去对稳定成年ICU患者中适度至重度液体过载的结果的影响.
主要方法:
- 国际,多中心,随机,分层,盲目,并行组,实用性临床试验.
- 1000名成年ICU患者中度至重度的液体过载随机 1:1 随机分配给罗塞米德或安慰剂.
- 主要结局:存活几天,并在随机化后90天内出院. 使用Kryger Jensen和Lange方法进行分析.
主要成果:
- 统计分析计划旨在检测初级结果的8%改善,90%的功率和5%的alpha.
- 主要分析将对治疗意向人口进行.
- 敏感性分析将在每个协议的人群中进行,并包括对预后变量进行调整.
结论:
- 预计GODIF试验数据将提高关于罗西米德在液体清除方面的效果的确定性.
- 这些发现将为管理成年ICU患者流体过载的临床实践提供信息.
- 该分析计划为评估罗塞米德在该人群中的疗效和安全提供了坚实的框架.
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