Double Blind Study of Hypertonic Saline vs Mannitol in the Management of Increased Intracranial Pressure (ICP).
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percent reduction of ICP from baseline
研究概览
简要总结
The study goal is to compare the management of increased intra-cranial pressure (ICP) using 3% hypertonic saline vs. mannitol (given in same osmolar loads).
Primary hypothesis:
- Hypertonic saline will be non-inferior to mannitol in decreasing elevated ICP.
Secondary hypotheses:
- Hypertonic saline therapy will result with fewer complications than mannitol
- ICP reduction duration will be longer using hypertonic saline when compared with mannitol
详细描述
There is growing evidence in the literature indicating that ICP and Cerebral Perfusion Pressure measurements may not be sufficient in the management of elevated ICP. Based on this evidence, monitoring of partial brain tissue oxygenation has gain acceptance among neurosurgeons and neurointensivists, and has become a standard of care monitor in some centers across the country. There is, however, insufficient information in the literature describing the effects of hyperosmolar medications on regional brain tissue oxygenation.
We intend to undertake this non-inferiority, prospective, randomized double-blind study to answer very important clinical questions not yet answered in the literature: Will hypertonic saline therapy, given at equiosmolar load, be non-inferior to mannitol in reducing elevated ICP?
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •elevated ICP requiring ICP monitoring
- •ICP ≥ 25 mmHg 5 min after ICP bolt or EVD placement
排除标准
- •Requiring decompressive craniotomy or post decompressive craniotomy
- •Hyponatremia (sodium level < 125 mEq/L)
- •Hypernatremia (sodium > 155 mmol/L)
- •Serum osmolality ≤ 250 mOsm/kg
- •Serum osmolality ≥ 320 mOsm/kg
- •Physical exam compatible with brain death
- •Patients on hemodialysis with end-stage renal disease
研究组 & 干预措施
hypertonic saline
3% hypertonic saline, dosed by ideal patient weight
干预措施: hypertonic saline (Drug)
Mannitol
20% mannitol, dosed by patient's ideal body weight
干预措施: Mannitol (Drug)
结局指标
主要结局
Percent reduction of ICP from baseline
时间窗: 30 minutes from completion of medication administration
次要结局
- Time from study drug administration completion to ICP < 25 mmHg(First 72 hours)
- Cumulative duration of ICP below 25 mmHg(First 72 hours)
- Cumulative duration of cerebral perfusion pressure (CPP) above 60 mmHg(First 72 hours)
- Cumulative duration of regional oxygen partial pressure (pbtO2) > 20%(two hours following each dose administration during the first 24 hours)
- Total dose of medications given(First 24 hours; also over 3 days)
- Frequency of treatment failure(First 72 hours)
- Frequency of rebound intracranial hypertension(First 72 hours)
- Frequency of composite Major Adverse Events(3 days)
- Difference in inflammatory response(Regular intervals over first 3 days)
- Difference in average pre-discharge stroke scale score(hospital discharge (or 30 days if not discharged))
研究者
Achikam Orin-Grinberg
Assistant Professor of Anaesthesia
Beth Israel Deaconess Medical Center