压力催化剂在儿科败血症休克中:实用,多中心,国际,随机,双盲,安慰剂控制的干预试验的协议
Kusum Menon1,2, Michael S D Agus3,4, Katie O'Hearn2
1Department of Pediatrics, Children's Hospital of Eastern Ontario, ON, Canada.
概括
这项研究调查了在儿科败血症休克中使用皮质类固醇的情况,这是一种具有高死亡率的疾病. 结果将澄清这一关键儿科疾病的治疗指南.
科学领域:
- 儿科重症监护医药 儿科重症监护医药
- 儿科重症儿童危急疾病
- 儿科重症监护病房 (PICU) 的研究.
背景情况:
- 感染性休克是儿童重症监护病房入院的重要原因,患病率和死亡率高.
- 目前关于儿童性休克时使用皮质类固醇的证据是不确定的,导致临床管理的不确定性.
- 现有的指导方针缺乏在这种患者群体中给予皮质类固醇的最终建议.
研究的目的:
- 评估皮在治疗儿科败血症休克时的疗效和安全性.
- 为基于证据的建议提供可靠的数据,建议在儿科败血症休克中使用皮质类固醇.
- 评估皮质类固醇对多器官功能障碍综合征和患者结局的影响.
主要方法:
- 一个务实,多中心,国际,随机,双盲,安慰剂控制的试验,涉及大约50个PICU.
- 招募多达500名被诊断患有败血性休克的儿科患者 (1个月至17岁8个月).
- 静脉注射皮醇 (2毫克/千克玻利素,然后每6小时1毫克/千克) 或安慰剂,直到静脉活性 - 诺托普输注停止12小时或最长7天.
主要成果:
- 测量的主要结果是28天内出现新的或进展的多器官功能障碍综合征的发生率.
- 二次结局包括死亡的复合或28天健康相关生活质量显著下降 (≥25%).
- 该研究旨在检测与皮质类固醇治疗相关的临床显著差异.
结论:
- 这项试验是第一个足够强大的儿科研究,用于评估性冲击中皮质类固醇的益处和风险.
- 研究结果将为未来的临床实践指南提供信息,用于管理儿科败血症休克.
- 最终的数据将指导在患有败血性休克的重症儿童中使用皮质类固醇的决定.
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