过水以改善 Shiga 毒素产生的大肠杆菌感染儿童的结局:一个跨国嵌入式集群交叉随机试验 (HIKO STEC试验)
Stephen B Freedman1, David Schnadower2, Myka Estes3
1Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Childrens Hospital, Alberta Childrens Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. stephen.freedman@albertahealthservices.ca.
Trials
|May 27, 2023
概括
过可能会防止严重的损伤的孩子与滋果毒素产生大肠杆菌 (STEC) 感染. 这项研究将测试积极的液体扩张是否与保守管理相比减少了主要的不良事件 (MAKE30).
科学领域:
- 儿科脏病学 儿科脏病学
- 传染性疾病 传染性疾病
- 关键护理医学 关键护理医学
背景情况:
- 滋果毒素产生大肠杆菌 (STEC) 感染会导致儿童发生血清性尿素综合征 (HUS),这是一种严重的疾病,有高透析率和死亡率.
- 目前对STEC感染的治疗是辅助性的,没有确定的治疗方法可以预防HUS的发展.
- 观察性研究表明,血管内体积膨胀 (过) 可能减轻末端器官损伤,需要严格的试验.
研究的目的:
- 为了确定与保守的流体管理相比,过水是否会改善高风险STEC感染儿童的结果.
- 评估过的有效性,以减少30天内严重的脏不良事件 (MAKE30).
- 评估超水对二次结果的影响,包括危及生命的外并发症和HUS发展.
主要方法:
- 一个务实,嵌入式,集群随机化,交叉试验,涉及26个儿科机构的1040名儿童.
- 过水路的比较 (200%的维持液体,目标是10%的体重增加/20%的血红素降低) 与保守的液体管理路径 (euvolemia焦点) 相比.
- 主要结局:MAKE30 (死亡,新的置换疗法或持续的功能障碍).
主要成果:
- 该研究旨在有90%的功率来检测MAKE30.30中5%的绝对风险降低.
- 据估计,在保守路径中的10%的儿童将经历主要结果.
- 0.11的类内相关系数 (ICC) 表明集群效应中等.
结论:
- 溶血性尿素综合征 (HUS) 是一种严重的疾病,缺乏有效的治疗选择.
- 这项实用性研究旨在提供证据,证明过能否降低高风险STEC感染儿童的HUS相关发病率.
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