| CTRI Number |
CTRI/2019/11/021849 [Registered on: 04/11/2019] Trial Registered Retrospectively |
| Last Modified On: |
07/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of intraoperative dextrose and insulin infusion in liver donor patients |
|
Scientific Title of Study
|
Effect of intraoperative dextrose infusion on postoperative hepatic functions in right living donor hepatectomy-randomised 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 |
NIDHI SINHA |
| Designation |
DNB ANAESTHESIOLOGY STUDENT |
| Affiliation |
INDRAPRASTHA APOLLO HOSPITALS |
| Address |
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA METRO STATION
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION 110025
South
DELHI
110025
India |
| Phone |
9899860805 |
| Fax |
|
| Email |
nidhi.sinha10@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRAMAN RAINA |
| Designation |
SENIOR CONSULTANT APOLLO HOSPITALS |
| Affiliation |
INDRAPRASTHA APOLLO HOSPITALS |
| Address |
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION 110025
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION 110025
South
DELHI
110025
India |
| Phone |
9958290493 |
| Fax |
|
| Email |
raina.raman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIDHI SINHA |
| Designation |
DNB ANAESTHESIOLOGY STUDENT |
| Affiliation |
INDRAPRASTHA APOLLO HOSPITALS |
| Address |
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION 110025
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION 110025
South
DELHI
110025
India |
| Phone |
9899860805 |
| Fax |
|
| Email |
nidhi.sinha10@yahoo.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL
The materials required are provided by the hospital
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION-110025 |
|
|
Primary Sponsor
|
| Name |
INDRAPRASTHA APOLLO HOSPITALS |
| Address |
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION-110025 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| NIDHI SINHA |
INDRAPRASTHA APOLLO HOSPITALS |
INDRAPRASTHA APOLLO HOSPITALS NEAR JASOLA APOLLO METRO STATION-110025 DEPT OF ANAESTHESIA
THESIS DONE IN OT AND FOLLOWED UP IN TRANSPLANT ICU OF INDRAPRASTHA APOLLO HOSPITALS
South
DELHI |
9899860805
nidhi.sinha10@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-CLINICAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers for surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
25% DEXTROSE |
DEXTROSE AND INSULIN WILL BE ADMINISTERED INTRAOPERATIVELY AND ALL VALUES INTRAOPERATIVELY AND POSTOPERATIVELY WILL BE RECORDED BY PRINCIPAL INVESTIGATOR
STUDY DURATION 1.5YEARS |
| Comparator Agent |
NORMAL SALINE AT SAME RATE OF 25% DEXTROSE |
DEXTROSE AND INSULIN WILL BE ADMINISTERED INTRAOPERATIVELY AND ALL VALUES INTRAOPERATIVELY AND POSTOPERATIVELY WILL BE RECORDED BY PRINCIPAL INVESTIGATOR DURATION OF STUDY IS 1.5 YEARS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I OR II PATIENTS OF EITHER SEX SCHEDULED FOR RIGHT LOBE DONOR HEPATECTOMY
AGE 18-60 YEARS |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with uncontrolled blood sugars
Patient with blood loss >1 litre
Patient with remnant liver volume <28 %
Patient with left lobe resection
Patient whose duration of surgery is more than 14 hours
Patient on beta blockers or calcium chanel blockers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LIVER FUNCTION TESTS ASSESSMENT ON INTRAOPERATIVE ADMINISTRATION OF DEXTROSE |
LIVER FUNCTION TESTS POSTOPERATIVE DAY 7
INTRAOPERATIVE LACTATE DIFFERENCE
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS RENAL FUNCTION TEST |
postoperative day 7 |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
Final Enrollment numbers achieved (Total)= "174"
Final Enrollment numbers achieved (India)="174" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2017 |
| Date of Study Completion (India) |
30/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a postgraduate thesis in Anaesthesiology regarding the effect of intraoperative dextrose and insulin infusion on postoperative hepatic functions.It is a randomised clinical trial.It was started from 1st January ,2017 after approval of Institutional Ethics Committee..Retrospective registration of the trial is being done |