| CTRI Number |
CTRI/2019/09/021032 [Registered on: 03/09/2019] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of hypertonic saline on fluid requirement during major abdominal surgery. |
|
Scientific Title of Study
|
Influence of 3% hypertonic saline on intraoperative maintenance fluid requirement in patients undergoing major abdominal surgery in comparison with 0.9% normal saline. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shri Hari Priya Behera |
| Designation |
Junior resident(Academic) |
| Affiliation |
All India Institute Of Medical Sciences,Bhubaneshwar |
| Address |
Department of Anaesthsiology and critical care,All India Institute of Medical Sciences, Bhubaneshwar
Sijua,Patrapada,bhubaneshwar
Khordha
ORISSA
751019
India |
| Phone |
7681826136 |
| Fax |
|
| Email |
priya.bhr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional Professor, Anaethesia |
| Affiliation |
All India Institute of Medical Sciences,Bhubaneshwar |
| Address |
Department of Anaesthesiology and critical care,AIIMS Bhubaneshwar
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Additional professor,Anaesthesia |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and critical care,AIIMS, Bhubaneshwar
Khordha
ORISSA
751019
India |
| Phone |
943888048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Bhubaneshwar |
| 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 Shri Hari Priya Behera |
All India Institute of Medical Sciences |
OT complex and ICU complex of AIIMS Bhubaneshwar, Patrapada
Khordha
ORISSA |
7681826136
priya.bhr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Normal saline |
0.9% Normal saline will be infused with a wide bore cannula @ 1 ml/kg/hr |
| Intervention |
3% Hypertonic saline |
3% Hypertonic saline will be infused through a wide bore cannula @ 1ml/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of ASA1 and ASA2
2. Surgeries lasting more than 2 hours
3. Expected hospital stay of more than 3 days
|
|
| ExclusionCriteria |
| Details |
1. Patients refusal to give consent
2. Inoperability
3. Emergency
4. Disturbances in serum sodium levels
5. Baseline elevated serum creatinine
6. Laproscopy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in intraoperative maintenance fluid requirements |
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Difference in 24hr fluid requirement
2. Need of vasopressors in 24hrs
3. Difference in arterial lactate level at 12 and 24 hrs
4. Difference in 24 and 48 hr serum creatinine
5.24hr CRP |
72 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2019 |
| Date of Study Completion (India) |
05/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective randomised control trial will seek to evaluate whether 3% hypertonic saline will reduce intra operative maintenance fluid requirement in patients undergoing major abdominal surgeries in comparison with normal saline. The study will comprise of 100 patients who will be divided into two groups;group 1 will receive 3% hypertonic saline via wide bore cannula at the rate of 1ml/kg/hr and group 2 will receive normal saline at the rate of 1ml/kg/hr. Both the groups will receive maintenance fluid to maintain a target of MAP>75mmHg, urine output of 0.5-1ml/kg/hr and CVP >8-10mmHg(wherever monitored). Primary outcome will be difference in intra operative maintenance fluid requirement. |