Intravenous fluid management in patients with acute hypertensive hemorrhagic stroke: A randomized controlled study
- Registration Number
- CTRI/2021/02/031504
- Brief Summary
This prospective, open label, outcome blinded, randomized controlled trial is planned to be conducted from February 2021 to February 2022, at Department of Neurology in IMS, BHU, Varanasi, a tertiary care teaching hospital in the state of Uttar Pradesh. Dehydration has poor prognosis on the outcome of both ischemic and hemorrhagic stroke. This has been well established by various studies, however the amount of intravenous fluid to be administered in the first few hours or days has not been established. There has been no randomized controlled trials studying the effect of same in hemorrhagic stroke or any guidelines for the same. Studies are required to investigate whether the amount of intravenous fluids in such patients would play a role in preventing early neurological deterioration and hence, improve outcomes. All the patients admitted to our hospital with acute hypertensive hemorrhagic stroke (based on clinical and radiological features) within a period of 72hrs from the onset of symptoms and consenting to be part of the study will be included after screening for inclusion and exclusion criteria. Sample size calculated is 210. Randomization will be done with the help of computer software. Patients will be randomly assigned to receive a hydration of 100ml/hr of 0.9% NaCl solution or no intravenous fluid. Hydration will be started within 1 hours of admission. For patients allocated to the 100ml/hr fluid group (IV fluid group), 0.9% NaCl solution will be administered intravenously at a rate of 100ml/hr for the first 72 hrs and will be encouraged to take same amount of fluid orally or through ryles tube as their previous intake. In the non-IV fluid group, no intravenous fluid will be given and will be encouraged to take same amount of fluid orally or through ryles tube as their previous intake. Neurologic condition will be assessed at admission, at 4 days of admission, at discharge and at 3 months after discharge by blinded outcome assessment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 210
All the patients admitted to our hospital with acute hypertensive hemorrhagic stroke (based on clinical and radiological features) within a period of 72hrs from the onset of symptoms and consenting to be part of the study will be included after screening for inclusion and exclusion criteria.
- 1.Not willing to participate in the study or no informed consent.
- 2.Those with GCS less than or equal to 8 at admission.
- 3.Prepared for or received surgical intervention within 14 days.
- 4.Patients with co-morbid conditions like cardiac failure, low ejection fraction (<40%), renal failure with admission serum creatinine more than 2, fluid overload, acute liver failure, liver cirrhosis, cancer under treatment, fever, or any conditions which require more aggressive hydration or blood or blood component transfusion at the time of admission.
- 5.Patients with sepsis, hypotension, DKA, electrolyte disturbances requiring urgent correction, requiring ICU admission or those with critical illness.
- 6.Life expectancy or any reasons for follow-up < 3 months.
- 7.Those who received fluid from other hospital before reaching our hospital.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with good outcome defined by mRS score of 0-3 3 months
- Secondary Outcome Measures
Name Time Method Duration of hospital stay At discharge Dehydration during hospital stay Till discharge Worsening of NIHSS score by more than or equal to 3 points unexplained by another cause Within 4days Cardiac failure or evidence of fluid overload Within 4days
Trial Locations
- Locations (1)
Neurology department, IMS, BHU
🇮🇳Varanasi, UTTAR PRADESH, India
Neurology department, IMS, BHU🇮🇳Varanasi, UTTAR PRADESH, IndiaDr Abhishek PathakPrincipal investigator8948512666abhishekpathakaiims@gmail.com