| CTRI Number |
CTRI/2026/02/103422 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of VExUS score for predicting kidney dysfunction after liver transplantation |
|
Scientific Title of Study
|
The correlation between Venous Excess Ultrasound score (VExUS) and acute kidney injury in patients undergoing living related liver transplantation. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sauharda Bikram Karki |
| Designation |
Clinical Fellow in Liver transplant anesthesia and critical care |
| Affiliation |
Max super speciality hospital, Saket |
| Address |
Max super speciality hospital, room no - 3501, 5th floor, Saket(West block), 1, Press enclave Road, Saket, New Delhi
South DELHI 110017 India |
| Phone |
9818102268 |
| Fax |
|
| Email |
sauhardak@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Suraj Deepak Desai |
| Designation |
Associate Consultant |
| Affiliation |
Max super speciality hospital, Saket |
| Address |
Max super speciality hospital, room no - 3501, 5th floor, Saket(West block), 1, Press enclave Road, Saket, New Delhi
South DELHI 110017 India |
| Phone |
9008726991 |
| Fax |
|
| Email |
soorajdesai57@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sauharda Bikram Karki |
| Designation |
Clinical Fellow in Liver transplant anesthesia and critical care |
| Affiliation |
Max super speciality hospital, Saket |
| Address |
Max super speciality hospital,room no - 3501, 5th floor, Saket(West block), 1, Press enclave Road, Saket, New Delhi
South DELHI 110017 India |
| Phone |
9818102268 |
| Fax |
|
| Email |
sauhardak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Superspeciality Hospital, West block, 1 Press enclave Marg, Saket, New Delhi -110017, India |
|
|
Primary Sponsor
|
| Name |
Max Superspeciality Hospital, Saket, New Delhi. |
| Address |
Max Superspeciality Hospital, West block, 2 press enclave Marg, Saket, New Delhi-110017
|
| 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 |
| Sauharda Bikram Karki |
Max super speciality hospital |
Department of anesthesia and critical care, Centre for Liver and biliary sciences, Room no 3419, LTP ICU 4th floor, West block, 1 press enclave Marg, Saket, New Delhi-110017 South DELHI |
9818102268
sauhardak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max HealthCare Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult Chronic liver disease (CLD) patients undergoing living related liver transplantation. |
|
| ExclusionCriteria |
| Details |
Patients with pre-operative AKI (KDIGO guidelines)
Patients with chronic kidney disease
Patient refusal. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association between venous congestion as estimated by VEXUS and the occurrence and severity of AKI in the postoperative period in patients undergoing living related liver transplantation. |
Post operative days 1,2 & 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of Renal Resistive Index and AKI in patients undergoing living related liver transplantation. |
Post operative days 1,2 & 3 |
|
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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)
|
23/02/2026 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a prospective observational study designed to evaluate the relationship between venous congestion assessed by the Venous Excess Ultrasound score and the development of acute kidney injury in adults undergoing living related liver transplantation. Acute kidney injury is a common postoperative complication after liver transplantation, with reported incidence of about fifty percent within the first seventy two hours, and early identification of contributing factors may help improve outcomes.
The study will be conducted at Max Superspeciality Hospital Saket over a period of nine months and will include adult patients with chronic liver disease undergoing living related liver transplantation. Patients with preoperative acute kidney injury, chronic kidney disease, or those who refuse consent will be excluded. A total of one hundred and five participants will be enrolled, accounting for expected attrition, based on prior data regarding the diagnostic performance of VExUS for predicting acute kidney injury.
All enrolled patients see standard preoperative evaluation and intraoperative anesthetic management as per institutional protocol. Postoperatively, patients will be monitored in the liver transplant intensive care unit. Venous Excess Ultrasound assessment will be performed at the bedside on postoperative days one two and three. The assessment includes measurement of inferior vena cava diameter and Doppler evaluation of hepatic vein portal vein and intrarenal venous flow to generate a VExUS grade ranging from zero to three indicating increasing severity of venous congestion. Renal resistive index will also be measured on the same days using Doppler ultrasound.
Renal function will be assessed daily until postoperative day three using serum creatinine urea estimated glomerular filtration rate and urine output. Acute kidney injury will be diagnosed and staged according to KDIGO criteria. The primary objective is to determine the association between VExUS grade and the occurrence and severity of postoperative acute kidney injury. The secondary objective is to assess the association between renal resistive index and acute kidney injury in this population.
Data will be analyzed using standard statistical methods to describe patient characteristics and to test associations between VExUS grades renal resistive index and acute kidney injury. Diagnostic performance measures and receiver operating characteristic analyses will be used where appropriate. The study involves no additional risk or cost to participants as all investigations are part of routine clinical care and all data will be handled confidentially in accordance with ethical guidelines. |