| CTRI Number |
CTRI/2025/02/080638 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of 3% Saline on optic nerve sheath size and its correlation with blood flow in the brain in patients with moderate to severe head injury |
|
Scientific Title of Study
|
3% Hypertonic saline induced changes in Optic Nerve Sheath Diameter (ONSD) and its correlation with Transcranial colour coded Duplex (TCCD) parameters in patients with moderate to severe Traumatic Brain Injury (TBI): A prospective observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pharanitharan |
| Designation |
Senior resident (Academic) |
| Affiliation |
All India institute of medical sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care,AICU(3rd floor),AIIMS Jodhpur ,Basni,industrial area phase 2 Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8012820356 |
| Fax |
|
| Email |
pharanitharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sadik Mohammed |
| Designation |
Additional professor |
| Affiliation |
All India institute of medical sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care,AICU(3rd floor),AIIMS Jodhpur, Basni,industrial area phase 2,Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9414849733 |
| Fax |
|
| Email |
drmsadik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pharanitharan |
| Designation |
Senior resident (Academic) |
| Affiliation |
All India institute of medical sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care,AICU(3rd floor)
,AIIMS Jodhpur,Basni,industrial area phase 2,Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8012820356 |
| Fax |
|
| Email |
pharanitharan@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences(AIIMSJodhpur),Basni industrial Area Phase-2,Jodhpur,Rajasthan,India.
PIN code-342005 |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care ,AICU(3rd floor), AIIMS Jodhpur ,Basni ,industrial area phase 2,Jodhpur |
| 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 Sadik Mohammed |
All India institute of medical sciences Jodhpur |
Department of Anaesthesiology & Critical care,AICU(3rd floor),AIIMS Jodhpur,Basni,industrial area phase 2,Jodhpur
Jodhpur
RAJASTHAN |
9414849733
drmsadik@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patient aged 18yrs and above
2.admitted in ICU
3.Diagnosed with Moderate/severe TBI requiring hypertonic saline therapy |
|
| ExclusionCriteria |
| Details |
1.patient refusal
2.preexisting optic nerve disorders
3.spontaneous intracranial haemorrhage,stroke
4.skull fractures
5.hemodynamic instability
6.brain stem death |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between change in ONSD and change in TCCD parameters following 3% hypertonic saline therapy in patients with moderate to severe traumatic brain injury TBI. |
Baseline,10mins and 1hr after hypertonic saline administration from ICU admission till day 5 of ICU or continuation of hypertonic saline therapy whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the correlation between changes in TCCD parameters and clinical improvement [change in Glasgow Coma Scale (GCS)] in patients with moderate to severe TBI following 3% hypertonic saline therapy.
2.To assess the correlation between changes in ONSD and clinical improvement (change in GCS) in patients with moderate to severe TBI following 3% hypertonic saline therapy.
3.To assess the effects of 3% hypertonic saline administration on electrolyte disturbances and hemodynamic parameters in patients with TBI.
4.To evaluate clinical outcomes including length of ICU stay, length of ventilatory stay, incidence of AKI, total hospital length of stay, and mortality rates |
1.GCS,serum electrolytes and hemodynamic parameters during ICU admission and till day 5 of ICU.
2.clinical outcomes will be noted till hospital stay or till the date of death in hospital |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
17/02/2025 |
| 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
|
After CTRI approval, our study will enroll patients with moderate to severe traumatic brain injury to observe the 3% hypertonic saline-induced changes in optic nerve sheath diameter (ONSD) and transcranial color-coded Doppler (TCCD) parameters and assess the correlation between them.
The primary objective is to establish a correlation between changes in ONSD and TCCD parameters following hypertonic saline therapy. Secondary objective is to assess the correlation between clinical improvement (change in GCS) with changes in TCCD parameters and ONSD in patients with moderate to severe TBI following hypertonic saline. To assess the effects of 3% hypertonic saline administration on electrolyte disturbances and hemodynamic parameters in patients with TBI. To evaluate clinical outcomes including length of ICU stay, length of ventilatory stay, incidence of AKI, total hospital length of stay, and mortality rates.
Data will be collected at baseline (before therapy) at the time of ICU admission, 10 minutes post-therapy, 1 hour post-therapy, and daily for 5 days or until the administration of hypertonic saline therapy, whichever is earlier. Clinical outcomes will be noted until hospital discharge or the date of death in the hospital. |