CTRI/2022/11/047736尚未招募不适用
To study the role of 3% hypertonic saline and mannitol in the reduction of raised intracranial pressure in children
departement of pediatrics1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- duration of coma
研究概览
简要总结
Cerebral edema is an important and frequent problem encountered in PICU. However all current treatment modalities are far from perfect and are associated with serious adverse events. other treatment modalities have been explored and hypertonic saline appears to be an appealing addition to the current therapeutic options and mannitol is still used extensively. hence we are undertaking this study to compare the efficacy of the most used hyperosmolar agents which are 3% saline and mannitol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •patients with signs of raised intracranial pressure.
排除标准
- •Children with gross congenital anomaly.
- •Hospital stay less than 8 hours.
- •Referred patient who has already recieved any hyperosmolar agent from outside.
结局指标
主要结局
duration of coma
时间窗: 72 hours
次要结局
- mortality(complications)
研究者
研究点 (1)
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