| CTRI Number |
CTRI/2025/07/090047 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of resuscitation by balanced salt solution and .9% nacl on traumatic patient to observe batter electrolyte balance |
|
Scientific Title of Study
|
Comparative study of saline versus balanced salt solution in initial resuscitation of trauma patient : A randomized and clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal singh chauhan |
| Designation |
Post graduate resident |
| Affiliation |
Gajra raja medical college gwalior |
| Address |
Room no2 department of emergency medicine gajra raja medical college gwalior madhyapradesh
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
6265109714 |
| Fax |
|
| Email |
vishal19november@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jitendra agrawal |
| Designation |
Hod and professor and guide |
| Affiliation |
Gajra raja medical college gwalior |
| Address |
Room no 1 department of emergency medicine gajra raja medical college gwalior madhyapradesh
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jitendra agrawal |
| Designation |
Hod and professor and guide |
| Affiliation |
Gajra raja medical college gwalior |
| Address |
Room no 1 department of emergency medicine gajra raja medical college gwalior madhyapradesh
Gwalior
MADHYA PRADESH
474001
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| vishal singh Chauhan
department of emergency medicine
room 3
grmc Gwalior
474009 |
|
|
Primary Sponsor
|
| Name |
vishal singh chauhan |
| Address |
room 3 department of emengency medicine
grmc galior 474009 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| vishal singh chauhan |
gajra raja medical college |
room no 4 department of emergency medicine
Gwalior
MADHYA PRADESH |
6265109714
vishal19november@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
.9% normal saline |
resuscitation by 0.9% normal saline of trauma patient in initial 24 hour of admission and cheak electrolyte balance of patient |
| Intervention |
balanced salt solution |
resuscitation of trauma patient by balanced salt in initial 24 hour of admission |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-trauma patients presenting within 24 hour of injury
-penetrating trauma to chest,abdomen or pelvis
-pelvis fracture
-shaft of femur fracture
-head injury |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fluid choice can affect restoration of acid base balance. balanced salt solution can do better electrolyte balance in trauma patient |
at 24 hours after giving resuscitation fluid |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in serum electrolyte levels,osmolality, lactate,arterial ph,inr and urine volume |
at 6 and 24 hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="10" |
|
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
|
Trauma patient often initially required significant resuscitation ..09 %nacl infusion associated with acidosis ,redused renal output ,gi disfunction and acute renal failure. balanced salt solution is a calcium free crystalloid that contains electrolyte concentration similar to plasma .it is compatible with blood and show the better acid base balance after injury or resuscitation. the present study aim to compare resuscitation with 0.9%nacl versus balanced salt solution , hypothesized that balanced salt solution would better correct the base deficit 24 hour after injury |