| CTRI Number |
CTRI/2022/11/047736 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
26/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
role of hypertonic saline versus mannitol in reducing cerebral edema in children |
|
Scientific Title of Study
|
To study the role of 3% hypertonic saline and mannitol in the reduction of raised intracranial pressure in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Razaq |
| Designation |
Professor |
| Affiliation |
Department of pediatrics government medical jammu |
| Address |
government medical college jammu, jammu and kashmir
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419124809 |
| Fax |
|
| Email |
drrazaq.razaq@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Razaq |
| Designation |
Professor |
| Affiliation |
Department of pediatrics government medical jammu |
| Address |
government medical college jammu, jammu and kashmir
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9419124809 |
| Fax |
|
| Email |
drrazaq.razaq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanni Slathia |
| Designation |
post graduate student |
| Affiliation |
Department of pediatrics government medical jammu |
| Address |
government medical college jammu, jammu and kashmir
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
9055504732 |
| Fax |
|
| Email |
nannipisean@gmail.com |
|
|
Source of Monetary or Material Support
|
| government medical college , jammu , j&k |
|
|
Primary Sponsor
|
| Name |
departement of pediatrics |
| Address |
governemnt medical college, bakshinagar, jammu, jammu and kashmir |
| 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 mohd razaq |
government medical college jammu |
emergency ward 18 and pediatric ICU centre, department of pediatrics SMGS hospital, shalamar, reshamghar colony, 180001
Jammu
JAMMU & KASHMIR |
9419124809
drrazaq.razaq@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE, JAMMU (IECGMCJ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G936||Cerebral edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3% hypertonic saline |
initial loading of 10ml/kg intravenous followed by 0.1ml/kg/hr will be done and compared to mannitol. |
| Comparator Agent |
mannitol |
initial loading dose of 0.5g/kg intavenous followed by 0.25 g/kg boluses every 6 hourly |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
patients with signs of raised intracranial pressure |
|
| ExclusionCriteria |
| Details |
1. Children with gross congenital anomaly.
2. Hospital stay less than 8 hours.
3. Referred patient who has already recieved any hyperosmolar agent from outside. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of coma |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
mortality
complications |
duration of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/11/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cerebral edema is an important and frequent problem encountered in PICU. However all current treatment modalities are far from perfect and are associated with serious adverse events. other treatment modalities have been explored and hypertonic saline appears to be an appealing addition to the current therapeutic options and mannitol is still used extensively. hence we are undertaking this study to compare the efficacy of the most used hyperosmolar agents which are 3% saline and mannitol. |