| 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
|
|
|
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
|
|
|
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. |