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
|
|
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
|
|
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. |