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CTRI Number  CTRI/2021/02/031504 [Registered on: 23/02/2021] Trial Registered Prospectively
Last Modified On: 06/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intravenous fluid]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intravenous fluid management in patients with acute hypertensive hemorrhagic stroke: A randomized controlled study 
Scientific Title of Study   Clinical outcome in patients with acute hypertensive hemorrhagic stroke with intravenous fluid versus no intravenous fluid: A randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Pathak 
Designation  Associate Professor, Neurology 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Neurology, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  8948512666   
Fax    
Email  abhishekpathakaiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Pathak 
Designation  Associate Professor, Neurology 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Neurology, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  8948512666   
Fax    
Email  abhishekpathakaiims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Favas T T 
Designation  Senior Resident, Neurology 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of Neurology, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  7875561819  
Fax    
Email  favas87@gmail.com  
 
Source of Monetary or Material Support  
IMS, BHU, Varanasi, Uttar Pradesh, India -221005 
 
Primary Sponsor  
Name  Institute of Medical Sciences Banaras Hindu University 
Address  Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh - 221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Pathak  Neurology department, IMS, BHU  IMS, BHU, Varanasi, Uttar Pradesh, India- 221005
Varanasi
UTTAR PRADESH 
8948512666

abhishekpathakaiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS, BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I61||Nontraumatic intracerebral hemorrhage, (2) ICD-10 Condition: I610||Nontraumatic intracerebral hemorrhage in hemisphere, subcortical, (3) ICD-10 Condition: I611||Nontraumatic intracerebral hemorrhage in hemisphere, cortical, (4) ICD-10 Condition: I613||Nontraumatic intracerebral hemorrhage in brain stem, (5) ICD-10 Condition: I614||Nontraumatic intracerebral hemorrhage in cerebellum, (6) ICD-10 Condition: I615||Nontraumatic intracerebral hemorrhage, intraventricular, (7) ICD-10 Condition: I616||Nontraumatic intracerebral hemorrhage, multiple localized, (8) ICD-10 Condition: I618||Other nontraumatic intracerebral hemorrhage, (9) ICD-10 Condition: I612||Nontraumatic intracerebral hemorrhage in hemisphere, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous fluid  0.9% NaCl solution will be administered intravenously at a rate of 100ml/hr for the first 72 hrs. They will be encouraged to take same amount of fluid orally or through ryles tube as their previous intake. Total duration of therapy is 72 hrs (intravenous fluid). 
Comparator Agent  Standard therapy  They will be encouraged to take same amount of fluid orally or through ryles tube as their previous intake. No intravenous fluids given. Total for 72 hrs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with good outcome defined by mRS score of 0-3  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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