A clinical trial to compare the efficacy and safety of intravenous hypertonic saline versus mannitol in patients of spontaneous intracranial haemorrhage

Phase 3

Not yet recruiting

• Conditions: Hemiplegia, unspecified,

• Registration Number: CTRI/2025/05/087854
• Lead Sponsor: AIIMS Bhubaneswar

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-19
• Study Start: 2025-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients of age 18 years or older 2.
• Spontaneous Supratentorial bleed requiring decongestant drugs as per clinician judgement.
• Not requiring immediate surgery at the time of randomization.

Exclusion Criteria

• Infratentorial bleed 2.
• Disability prior to onset of present stroke (pre stroke MRS more than/ equal to 4) 3.
• Venous strokes 4.
• Known case of chronic kidney disease 5.
• Pregnancy and lactation 6.
• Traumatic brain injury 7.
• Extradural/ subdural/ subarachnoid haemorrhage 8.
• Bleeding into brain SOL 9.
• Patients with terminal illness/ palliation with life expectancy less than / equal to 6 months.
• Patients undergoing surgery at the time of randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess Change in GCS score	on day 10 of admission from | baseline at admission

Secondary Outcome Measures

Name	Time	Method
1. To assess Other clinical parameters of raised ICP (	bradycardia, hypertension, respiration variability , pupillary

Trial Locations

Locations (1)

AIIMS Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

AIIMS Bhubaneswar

🇮🇳Khordha, ORISSA, India

DR RITUPARNA BERA

Principal investigator

6295113480

rituparnabera2012@gmail.com