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CTRI Number  CTRI/2025/10/096522 [Registered on: 28/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing two treatments mannitol with hypertonic saline versus hypertonic saline alone to find which is better and safer in reducing brain pressure in patients with stroke. 
Scientific Title of Study   Comparative Efficacy and Safety of 3percent Hypertonic Saline Plus Mannitol versus 3percent Hypertonic Saline Alone in Lowering Intracranial Pressure based on Optic Nerve Sheath Diameter in Stroke Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Keshav Rajput 
Designation  Junior resident 
Affiliation  AIIMS JODHPUR 
Address  Department of Trauma and Emergency AIIMS JODHPUR Heavy Industrial Area Phase II Basni Jodhpur Rajasthan 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  9882728253  
Fax    
Email  keshavrajput024@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghavendra Kumar Sharma 
Designation  Associate Professor 
Affiliation  AIIMS JODHPUR 
Address  Department of Trauma and Emergency AIIMS Jodhpu Heavy Industrial Area Phase II Basni Jodhpur Rajasthan 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  8076472804  
Fax    
Email  sdr.raghavendra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Keshav Rajput 
Designation  Junior resident 
Affiliation  AIIMS JODHPUR 
Address  Department of Trauma and Emergency AIIMA Jodhpur Heavy Industrial Area Phase II Basni Jodhpur Rajasthan 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  9882728253  
Fax    
Email  keshavrajput024@gmail.com  
 
Source of Monetary or Material Support  
Department of Trauma and Emergency AIIMS Jodhpur Heavy industrial area Phase 2 Basni Jodhpur Rajasthan Pin code 342005 INDIA 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  AIIMS Jodhpur Heavy Industrial Area Phase II Basni Jodhpur Rajasthan 342005 India 
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 Keshav Rajput  AIIMS JODHPUR  Department of Trauma and Emergency AIIMS Jodhpur Heavy Industrial Area Phase II Basni Jodhpur Rajasthan 342005 India
Jodhpur
RAJASTHAN 		 9882728253

keshavrajput024@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (2) ICD-10 Condition: I610||Nontraumatic intracerebral hemorrhage in hemisphere, subcortical, (3) ICD-10 Condition: I612||Nontraumatic intracerebral hemorrhage in hemisphere, unspecified, (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: I611||Nontraumatic intracerebral hemorrhage in hemisphere, cortical, (10) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, (11) ICD-10 Condition: I630||Cerebral infarction due to thrombosis of precerebral arteries, (12) ICD-10 Condition: I631||Cerebral infarction due to embolism of precerebral arteries, (13) ICD-10 Condition: I632||Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries, (14) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries, (15) ICD-10 Condition: I635||Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries, (16) ICD-10 Condition: I638||Other cerebral infarction, (17) ICD-10 Condition: G936||Cerebral edema, (18) ICD-10 Condition: G932||Benign intracranial hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  3 PERCENT HYPERTONIC SALINE  3 PERCENT HYPERTONIC SALINE FOR REDUCING INTRACRANIAL PRESSURE IN STROKE PATIENTS 
Intervention  3 PERCENT HYPERTONIC SALINE AND MANNITOL COMBINE IN REDUCING RAISED INTRACRANIAL PRESSURE   CAN 3 PERCENT HYPERTONIC SALINE AND MANNITOL IS ABLE TO REDUCE INTRACRANIAL PRESSURE BETTER THAN 3 PERCENT HYPERTONIC SALINE ALONE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Adult patients who are 18 years of age or older.

2. Acute stroke diagnosis (ischemic or haemorrhagic) confirmed by brain imaging with CT or MRI.
3. Clinical or radiological indications of high intracranial pressure (ICP): These include symptoms including cerebral Edema, papilledema, midline shift, diminished consciousness, obliteration of the basal cisterns, and ONSD greater than 5.0 mm.
4. Hemodynamically stable upon enrolment: Systolic blood pressure of 90 mmHg or above without inotropic assistance.
5. Based on clinical assessment, hyperosmolar treatment is anticipated to be necessary as part of routine ICP management.
6. Consent from the patient or their duly appointed representative
7. GCS score between 6-13
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the reduction in ONSD in stroke patients receiving 3% hypertonic saline alone vs. those receiving 3% hypertonic saline with mannitol.  baseline , 1 hour, 6 hour , 12 hour and 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate clinical improvement using tools like the NIH Stroke Scale & Glasgow Coma Scale.
• To compare the incidence of adverse effects (renal dysfunction, electrolyte imbalance, rebound, ICP etc.) between the group.
• To evaluate functional result (e.g., mRS)
.Assessing hospital mortality; comparing hospital stay duration; & determining whether further surgical decompression is required
 		 Clinical improvement (NIHSS, GCS) at baseline, daily Day 1–3, & discharge; adverse effects (renal, electrolytes) daily & end of therapy; functional outcome (mRS) at discharge, optional 1-month follow-up; hospital mortality; hospital stay duration; need for surgical decompression recorded during hospitalization. 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
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)   05/11/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Mannitol reduces cerebral Edema by acting as an osmotic diuretic, which pulls water from the brain parenchyma into the vascular compartment and lowers ICP. Nevertheless, electrolyte imbalances and hypovolemia may result from its diuretic action.
By raising serum osmolality and encouraging water to migrate from the intracellular to the extracellular region, hypertonic saline (3percent NaCl) lessens cerebral Edema. Additionally, it increases cerebral perfusion pressure and plasma volume without causing appreciable diuresis.
Because of the continuity of the subarachnoid space, the optic nerve sheath diameter (ONSD) reflects intracranial pressure.

• Null Hypothesis  There is no difference in efficacy or safety between the combination of 3percent hypertonic saline plus mannitol and 3% hypertonic saline alone in reducing intracranial pressure in stroke patients.
• Alternative Hypothesis  The combination of 3percent hypertonic saline and mannitol is more effective and equally safe compared to 3% hypertonic saline alone in reducing intracranial pressure in stroke patients.


 
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