| CTRI Number |
CTRI/2024/12/078594 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Cerebral oxygenation during live donor liver transplant surgery and its effect on post operative cognitive dysfunction |
|
Scientific Title of Study
|
Near infra red spectroscopy (NIRS) targeted goal directed therapy for intra operative hemodynamics & its
impact on post operative neurological complications in Living donor liver transplant recipients A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi singh |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary science New Delhi |
| Address |
Room no 502 pragyaan hostel institute of liver and biliary science Vasant Kunj block D2 New Delhi
Plot no 34 behind Beltarodi police station Beltarodi Nagpur Maharashtra
New Delhi
DELHI
110070
India |
| Phone |
8358052071 |
| Fax |
|
| Email |
nidhisingh961991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi singh |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary science New Delhi |
| Address |
Room no 502 institute of liver and biliary science Vasant Kunj block D2 New Delhi
Institute of liver and biliary science Vasant Kunj block D2 New Delhi
New Delhi
DELHI
110070
India |
| Phone |
8358052071 |
| Fax |
|
| Email |
nidhisingh961991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
Associate Professor |
| Affiliation |
Institute of liver and biliary science Vasant Kunj New Delhi |
| Address |
Institute of liver and biliary science Vasant Kunj New Delhi
New Delhi
DELHI
110070
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology 3rd floor phase 2, Institute of liver and biliary science ,New Delhi India , pin -110070 |
|
|
Primary Sponsor
|
| Name |
Dr Nidhi Singh |
| Address |
Room no 502 pragyaan building Institute of liver and biliary science Vasant Kunj New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gaurav Sindwani |
Institute of liver and biliary science New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Singh |
Institute of Liver and Biliary Science |
Department of Anaesthesiology, 3rd floor phase 2 building
South
DELHI |
8358052071
nidhisingh961991@gmail.com |
| Dr Nidhi singh |
New Delhi |
Institute of liver and biliary science
South
DELHI |
8358052071
nidhisingh961991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ILBS |
Approved |
| Institutional ethics committee ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K721||Chronic hepatic failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Increment in fiO2 |
If even after increment of mean arterial pressure upto 80 mm hg is unable to maintain NIRS then fio2 will be increased up to 70% |
| Intervention |
Increment in mean arterial pressure |
Increment of mean arterial pressure up to 80 mm hg if fall in NIRS more than 20 % |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Transfusion of PRBC |
if even after increment in MAP and fio2 NIRS is still low ( 20% fall ) PRBC will be transfused to maintain hematocrit 25 % |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients between 18 to 65 years old undergoing living donor liver transplant |
|
| ExclusionCriteria |
| Details |
Patients with acute liver failure
Patients with neurological disorders
Patients with pre operative AKI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of incidence of post operative cognitive dysfunction between NIRS based goal directed
therapy and non goal directed therapy group. |
Post operative day 7 and post operative day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of incidence of AKI in both groups |
Post op day 7 and day 28 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/01/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
NIRS in non invasive monitoring to assess cerebral oxygenation during. Previous studies has already shown correlation between NIRS and post operative cognitive dysfunction , although NIRS guided goal directed therapy and its impact on post operative neurological disorders. |