| CTRI Number |
CTRI/2016/04/006829 [Registered on: 18/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
13/04/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of 2 drugs to manage brain swelling in patients with head injury |
|
Scientific Title of Study
|
A comparative study of 3% Hypertonic saline and 20% mannitol in the treatment of refractory post traumatic intracranial hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anirudh TJ Dr Shibu Pillai |
| Designation |
Senior Resident |
| Affiliation |
NIMHANS |
| Address |
Department of Neurosurgery, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829727 |
| Fax |
|
| Email |
anirudhbmc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GS Umamaheswara Rao |
| Designation |
Senior Professor |
| Affiliation |
NIMHANS |
| Address |
Dr GS Umamaheswara Rao, Dept of Neuroanesthesia
NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829727 |
| Fax |
|
| Email |
gsuma123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anirudh TJ |
| Designation |
Senior Resident |
| Affiliation |
NIMHANS |
| Address |
Department of Neurosurgery, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829727 |
| Fax |
|
| Email |
anirudhbmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Neurorointensive care unit, NIMHANS |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
NIMHANS, Hosur, Road, Bangalore 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anirudh TJ |
NIMHANS |
Neurointensive care unit, Neurocentre, 2nd Floor, NIMHANS, Bangalore 560029
Bangalore
KARNATAKA |
080-26995416
anirudhbmc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Traumatic Brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hypertonic saline |
3% hypertonic saline
frequency:every time ICP increases 20 mmHg
route:intravenous
Duration: 6 days |
| Intervention |
mannitol |
20% mannitol
frequency:every time ICP increases 20 mmHg
route:intravenous
Duration: 6 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
within 24 hours of traumatic brain injury |
|
| ExclusionCriteria |
| Details |
Pregnancy
GCS 3
Absent brainstem reflexes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the intracranial pressure |
every 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in cerebral perfusion pressure |
daily for six days |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/05/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
An equiosmolar study on early intracranial physiology and long term outcome in severe traumatic brain injury comparing mannitol and hypertonic saline.
Jagannatha AT, Sriganesh K, Devi BI, Rao GS.
J Clin Neurosci. 2016 Feb 25. pii: S0967-5868(15)00605-0. doi: 10.1016/j.jocn.2015.08.035. [Epub ahead of print] |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aimed at evaluating hypertonic saline with traditionally used mannitol in patients with severe traumatic brain injury. |