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在小儿术后和创伤患者中,限制与自由结晶体流体管理的试点随机对照试验
Vincent P Duron1, Rika Ichinose2, Latoya A Stewart3
1Division of Pediatric Surgery, Morgan Stanley Children's Hospital/New York-Presbyterian, Columbia University College of Physicians & Surgeons, , 3959 Broadway, CHN 215, New York, NY, 10032, USA. vd2312@cumc.columbia.edu.
Pilot and feasibility studies
|November 8, 2023
概括
这项试点研究发现,在重症儿科患者中,限制静脉注射 (IV) 液体管理是可行的和安全的. 趋势表明,限制液体的肺部结果有所改善,这需要进一步研究.
科学领域:
- 儿科重症监护医药 儿科重症监护医药
- 流体复苏策略 流体复苏策略
- 临床试验方法论 临床试验方法论
背景情况:
- 静脉注射 (IV) 液体治疗对于儿科手术和创伤患者至关重要.
- 激烈的液体管理可能是有害的.
- 需要进行前性研究,比较自由与受限制的流体管理.
研究的目的:
- 评估在儿科重症监护中随机对照试验 (RCT) 的可行性.
- 评估流体管理RCT的招聘和保留率.
- 收集关于流体管理策略的安全性和临床结果的初步数据.
主要方法:
- 一个由两部分组成的试点随机对照试验 (RCT),涉及50名儿科术后和创伤患者.
- 自由 (高容量) 与限制 (低容量) 结晶体流体管理的比较.
- 在最初的29名患者之后,算法得到了改进;使用了未盲目的,受阻的随机化.
主要成果:
- 在研究的第二部分中,招聘和保留标准得到了满足 (54%的入学率,71%的完成率).
- 没有任何不良事件归因于研究干预措施.
- 在算法修订后,在限制液体管理的情况下,观察到改善肺部结果 (氧气,通风) 的非显著趋势.
结论:
- 在重症儿科患者中比较自由和限制液体管理的单位RCT是可行的和安全的.
- 限制流体管理显示了改善肺部结果的趋势.
- 建议进行最终的多中心RCT来证实这些发现.
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