NCT07519226已完成不适用
Effectiveness and Safety of Penehyclidine Hydrochloride for Improving Microcirculatory Dysfunction in Critically Ill Children: A Single-Center, Prospective, Randomized Controlled Trial
Lihua Wen1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2024年5月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- the duration of CRT(capillary refill time)
研究概览
简要总结
This prospective randomized controlled trial was designed to evaluate whether the M1/M3-selective antagonist penehyclidine hydrochloride could more effectively reverse pediatric microcirculatory dysfunction than traditional atropine, particularly when macrohemodynamics appear normalized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients (aged 28 days to 18 years) admitted with shock who exhibited persistent microcirculatory impairment despite achieving macrohemodynamic stability (normalized mean arterial pressure) through standardized initial resuscitation.
- •presence of at least one of the following clinical markers: (1) capillary refill time (CRT)≥ 3 seconds; (2) serum lactate > 2 mmol/L; (3) cool extremities; or (4) a core-to-peripheral temperature gradient ≥ 2°C.
排除标准
- •refusal of informed consent;
- •congenital cardiovascular malformations or known inherited metabolic disorders;
- •disease severity precluding reliable microcirculatory monitoring;
- •patients undergoing therapeutic hypothermia, which inherently alters vasomotor tone.
研究组 & 干预措施
Control Group
Active Comparator
atropine
干预措施: atropine control group (Drug)
Experimental group
Experimental
penehyclidine hydrochloride
干预措施: penehyclidine hydrochloride group (Drug)
结局指标
主要结局
the duration of CRT(capillary refill time)
时间窗: 7 days
次要结局
未报告次要终点
研究者
Lihua Wen
Director
Guangzhou Women and Children's Medical Center
研究点 (1)
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