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临床试验/CTRI/2025/05/087854
CTRI/2025/05/087854尚未招募3 期

Comparison of efficacy and safety profile of intravenous hypertonic saline versus mannitol in patients with spontaneous intracranial haemorrhage - a randomized controlled trial

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月25日最近更新:

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)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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