Comparison of efficacy and safety profile of intravenous hypertonic saline versus mannitol in patients with spontaneous intracranial haemorrhage - a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess Change in GCS score
研究概览
简要总结
Stroke is a leading cause of mortality,and long term disability worldwide, that significantly impacts global public health . Overall, Intracerebral haemorrhage (ICH) represents approximately10-15%of all strokes worldwide, but imposes significant morbidity& mortality among adults globally,making it significantly impacting global public health. Deleterious outcomes in ICH are a result of primary and secondary pathologic insults. Primary ICH insult is inflicted mostly by mechanical mass effect secondary to clot formation. Further neurological deterioration in ICH patients can occur due to delayed insult secondary to hematoma growth, intraventricular expansion, and peri hematomal edema. Hematomal masseffect, evolving perihematomal edema, and perihematomal growth can result in decreased cerebral perfusion pressure(CPP), increased intracranial pressure (ICP), and herniation .Monitoring and managing ICP is essential inr educing the ris kof brain herniation,ischemia,and further damage. Although decompressive craniectomy (DC) can reduce the mortality rate 38%, intravenous hyperosmolar therapy mannitol or hypertonic normal saline (3%NS) is still an important noninvasiveoption.Both agents work by creating an osmotic gradient that draws fluid out of the brain tissue, but their mechanism & neuroprotective effects may differ. Mannitol is a most commonly used and first–line osmotic agent,considered gold standard for ICP management. But 3% NS due to its osmotic effects and ability to reduce inflammatory responses, is a promising alternative, with several studies showing its enhanced potency over mannitol in patients with traumatic brain injury. But major flaw in those studies was use of varying and non equiosmolar concentration, that makes it difficult to find the most appropriate osmolar agent with salutary effect on ICP. Besid test here is scant literature on the safety,effectiveness,and scope of application of 3% NS in spontaneous ICH.Also, there was scant studies to compare the efficacy of mannitol and hypertonic saline among ICH patients. Hence, this randomized controlled study was designed to comparetheefficacyofequi-osmolarsolutionsof3%NSand 20%mannitol basedonchange inGCS, andother clinical & radiologicalparameters,andfunctionaloutcome
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age 18 years or older
- •Spontaneous Supratentorial bleed requiring decongestant drugs as per clinician judgement.
- •Not requiring immediate surgery at the time of randomization.
排除标准
- •Infratentorial bleed
- •Disability prior to onset of present stroke (pre stroke MRS more than/ equal to 4)
- •Venous strokes
- •Known case of chronic kidney disease
- •Pregnancy and lactation
- •Traumatic brain injury
- •Extradural/ subdural/ subarachnoid haemorrhage
- •Bleeding into brain SOL
- •Patients with terminal illness/ palliation with life expectancy less than / equal to 6 months.
- •Patients undergoing surgery at the time of randomization.
结局指标
主要结局
To assess Change in GCS score
时间窗: on day 10 of admission from | baseline at admission
次要结局
- 1. To assess Other clinical parameters of raised ICP ((bradycardia, hypertension, respiration variability , pupillary)
