在重症患者 (REPLENISH) 随机临床试验中通过肠道营养逐步方法替代蛋白质的统计分析计划
Yaseen M Arabi1, Hasan M Al-Dorzi2, Omar Aldibaasi3
1Intensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. arabi@ngha.med.sa.
Trials
|May 2, 2024
概括
这项研究调查了重症患者的高与中等蛋白质摄入量. 结果将确定最佳的蛋白质策略,以减少重症监护室患者的死亡率.
科学领域:
- 关键护理医学 关键护理医学
- 营养科学 营养科学
背景情况:
- 危急病患者的最佳蛋白质摄入量仍未确定.
- REPLENISH试验调查了高蛋白肠道营养与标准蛋白质水平的对比.
研究的目的:
- 评估高蛋白摄入量是否降低机械通风ICU患者的90天死亡率.
- 评估蛋白质补充对功能结果和生活质量的影响.
主要方法:
- 一个多中心随机试验,涉及2502名重症患者.
- 患者通过肠道营养获得高蛋白质 (2-2.4 g/kg/天) 或中等蛋白质 (0.8-1.2 g/kg/天).
- 主要终点是90天全因死亡率.
主要成果:
- 该研究以80%的功率设计,以检测5%的绝对死亡风险降低.
- 建立统计分析计划,以便对初级和二级结果进行公正的评估.
结论:
- 从多个机构审查委员会获得的道德认可.
- 结果将在同行评审期刊上发表,并在会议上发表.
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