NCT07304947招募中不适用
Personalized Cardiac Index-Guided Intraoperative Hemodynamic Management to Improve Postoperative Outcomes in Pediatric Patients With Moyamoya Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Incidence of transient ischemic episodes during hospitalization
研究概览
简要总结
This prospective randomized controlled trial evaluates whether individualized cardiac index-guided intraoperative hemodynamic management reduces postoperative transient ischemic episodes in pediatric patients undergoing encephaloduroarteriosynangiosis (EDAS) for Moyamoya disease. Patients are randomized 1:1 to goal-directed fluid therapy based on baseline cardiac index versus standard arterial pressure-based management. The primary outcome is the incidence of transient ischemic episodes during hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients <18 years undergoing EDAS for Moyamoya disease under general anesthesia
排除标准
- •ASA physical status 4-5
- •Emergency surgery
- •Known cardiovascular disease
- •Any condition judged inappropriate by investigators
结局指标
主要结局
Incidence of transient ischemic episodes during hospitalization
时间窗: Postoperative hospital stay
From end of surgery through postoperative hospital discharge, up to 7 days
次要结局
- Duration of anesthesia(Intraoperative period)
- Length of ICU stay(From postoperative Day 0 through ICU discharge, assessed up to 14 days)
- Percentage of anesthesia time with MAP deviating >20% from baseline(Intraoperative period)
- Percentage of anesthesia time with cardiac index deviating >20% from baseline(Intraoperative period)
- Duration of postoperative mechanical ventilation(From end of surgery until extubation, assessed up to 24 hours)
- MRI-confirmed intracranial hemorrhage(From postoperative Day 0 through Day 7)
- Length of hospital stay(From postoperative Day 0 through Day 7)
- MRI-confirmed postoperative cerebral infarction(From postoperative Day 0 through Day 7)
- Intraoperative fluid volume administered(Intraoperative period)
- Intraoperative vasoactive agent dose(Intraoperative period)
- Intraoperative urine output(Intraoperative period)
- Estimated blood loss(Intraoperative period)
研究者
Eun-hee Kim
professor
Seoul National University Hospital
研究点 (1)
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