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CTRI Number  CTRI/2024/10/075262 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Is hypertonic saline the medicine used for patients with head injury causing low sodium levels when compared to mannitol 
Scientific Title of Study   Is hypertonic saline causing delayed hyponatremia in traumatic brain injury patients undergoing osmotherapy – A randomized controlled trial between hypertonic saline and mannitol  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kent Reji K 
Designation  Senior Resident 
Affiliation  Christian Medical College, Vellore  
Address  Department of Neurological Sciences, Christian Medical College Vellore – Ranipet campus, Kilminnal village

Vellore
TAMIL NADU
632517
India 
Phone  7598280733  
Fax    
Email  kentrejik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mathew Joseph 
Designation  Professor 
Affiliation  Christian Medical College, Vellore  
Address  Department of Neurological Sciences, Christian Medical College Vellore – Ranipet campus, Kilminnal village

Vellore
TAMIL NADU
632517
India 
Phone  9894032018  
Fax    
Email  mjoseph@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Mathew Joseph 
Designation  Professor 
Affiliation  Christian Medical College, Vellore  
Address  Department of Neurological Sciences, Christian Medical College Vellore – Ranipet campus, Kilminnal village


TAMIL NADU
632517
India 
Phone  9894032018  
Fax    
Email  mjoseph@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College, Ida Scudder Road, Vellore, Tamil Nadu, India - 632004 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Christian Medical College Vellore, Ida Scudder Road, Vellore - 632004 
Type of Sponsor  Private 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 Kent Reji K  Christian Medical College Vellore  Department of Neurological Sciences. Fourth floor. Ranipet campus. Kilminnal Village. Ranipet District. Tamilnadu, India. Pincode: 632517.
Vellore
TAMIL NADU 
7598270733

kentrejik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Review Board (Silver Ethics and Research Committee) of the Christian Medical College Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S061||Traumatic cerebral edema,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20% Mannitol  If weight less than 80 kgs, 20% Mannitol administered at 100 mL Q6H x 8 doses (2 days) followed by 50 ml Q6H (1 day) x 4 doses and stopped. If weight more than 80 kgs, 20% Mannitol administered at 150 mL Q6H x 8 doses (2 days) followed by 75 ml Q6H x 4 doses (1 day) and stopped. Total duration - 3 days.  
Intervention  3% NaCl  If weight less than 80 kgs, 3% NaCl administered at 100 mL Q6H x 8 doses (2 days) followed by 50 ml Q6H x 4 doses (1 day) and stopped. If weight more than 80 kgs, 3% NaCl administered at 150 mL Q6H x 8 doses (2 days) followed by 75 ml Q6H (1 day) x 4 doses and stopped. Total duration of intervention - 3 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients above the age of 18 years admitted following traumatic brain injury requiring osmotherapy. 
 
ExclusionCriteria 
Details  Patients with serum sodium level less than 135 mmol/L at admission.
Patients receiving diuretics or patients with renal failure – AKI/CKD.
Patients who require surgery within the first 24 hours of admission.
Patients who were primarily managed elsewhere.
Patients with bilaterally fixed and non-reactive pupils.
Pregnant women.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of delayed hyponatremia defined as serum sodium dropping below 135 mmol/L after the initiation of osmotherapy and within seven days of trauma.  Within seven days of trauma. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of ICU stay.
Duration of hospital stay.
Requirement of Fludrocortisone.
Need for surgical intervention
Development of hyperchloremic metabolic acidosis. 
Within seven days of trauma. 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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   Phase 4 
Date of First Enrollment (India)   25/10/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Traumatic brain injury patients are routinely treated with osmotherapy such as mannitol and/or hypertonic saline for reducing the intracranial pressure. We observed that these patients are developing hyponatremia after 3-5 days of being given osmotherapy and this delayed hyponatremia led to prolongation of hospital stay and requirement of additional medications such as Fludrocortisone. We also observed that delayed hyponatremia was seen more commonly in patients treated with hypertonic saline when compared to those treated with mannitol. This has not been reported in literature. Hence, we designed this randomized controlled trial where patients with traumatic brain injury requiring osmotherapy will be randomized to receive either hypertonic saline or mannitol and we will assess the incidence of delayed hyponatremia in both groups and the relative risk as the primary outcome measure. We will also study the secondary outcome measures such as duration of ICU/hospital stay, requirement of Fludrocortisone and/or Prednisolone and need for surgical intervention. This study will help us to assess if the delayed hyponatremia seen in traumatic brain injury patients undergoing osmotherapy can be attributed to the use of hypertonic saline and whether preference to use mannitol instead of hypertonic saline as the first osmotherapeutic agent in traumatic brain injury patients can be justified.

 
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