高血压对比标准血压目标在高血压高风险患者接受选择性主要腹部手术:HISTAP随机临床试验的研究方案
Antonio Messina1,2, Andrea Cortegiani3, Stefano Romagnoli4
1Department of Biomedical Sciences, Humanitas University, Via Rita Levi Moltancini 4, Pieve Emanuele (MI), 20072, Italy. antonio.messina@humanitas.it.
Journal of anesthesia, analgesia and critical care
|December 2, 2023
概括
这项研究调查了手术期间更高的平均动脉压 (MAP) 目标是否能改善高血压患者的结果. 结果将指导在高风险的手术病例中进行最佳的手术内血压管理.
科学领域:
- 麻醉学 麻醉学
- 关键护理医学 关键护理医学
- 手术瘤学手术瘤学
背景情况:
- 术内低血压很常见,特别是在接受重大手术的高血压患者中.
- 这些患者的最佳平均动脉压 (MAP) 目标仍然不清楚.
- HISTAP试验协议解决了这一知识差距.
研究的目的:
- 在高风险高血压患者中,确定更高的手术内MAP目标 (≥80 mmHg) 与标准目标 (≥65 mmHg) 相比,改善了术后的结果.
- 为了评估30天死亡率和主要器官功能障碍或败血症的复合结果.
主要方法:
- 一个实用的,并行分组的,随机的临床试验,涉及636名患者.
- 分层随机化以更高的MAP目标 (≥80 mmHg) 或标准的MAP目标 (≥65 mmHg).
- 主要结局:30天死亡率和主要器官并发症的组合. 二次结果包括ICU停留,SOFA分数和重新操作率.
主要成果:
- 主要结果分析将使用未调整的奇二测试.
- 考克斯的比例危险模型将根据基线共变量进行调整.
- 结果将为对手术内MAP目标的临床决策提供信息.
结论:
- 希斯塔普试验将为高危高血压患者的手术内MAP目标提供关键证据.
- 这些发现将指导临床实践在重大腹部手术期间管理血压.
- 这项研究旨在优化患者的治疗结果,减少并发症.
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