| CTRI Number |
CTRI/2026/02/104765 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
What Happens When Blood Flow Is Restored During Liver Transplant Surgery : How It Affects the New Liver and Patient Recovery |
|
Scientific Title of Study
|
Post Reperfusion Syndrome In Living Donor Liver Transplantation: Incidence, Predictors, and Impact on Early Allograft Dysfunction and Patient Outcomes |
| 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 Eshita Singh |
| Designation |
Anaesthesiologist |
| Affiliation |
Medanta The Medicity Hospital, Gurugram |
| Address |
Department of Liver Transplant and GI Anaesthesia, Medanta The Medicity Hospital, Gurugram 122001
Gurgaon HARYANA 122001 India |
| Phone |
9902145542 |
| Fax |
|
| Email |
hanakoeshi07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Eshita Singh |
| Designation |
Anaesthesiologist |
| Affiliation |
Medanta The Medicity Hospital, Gurugram |
| Address |
Department of Liver Transplant and GI Anaesthesia, Medanta The Medicity Hospital, Gurugram 122001
Gurgaon HARYANA 122001 India |
| Phone |
9902145542 |
| Fax |
|
| Email |
hanakoeshi07@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Eshita Singh |
| Designation |
Anaesthesiologist |
| Affiliation |
Medanta The Medicity Hospital, Gurugram |
| Address |
Department of Liver Transplant and GI Anaesthesia, Medanta The Medicity Hospital, Gurugram 122001
Gurgaon HARYANA 122001 India |
| Phone |
9902145542 |
| Fax |
|
| Email |
hanakoeshi07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018 |
|
|
Primary Sponsor
|
| Name |
Dr Eshita Singh |
| Address |
Medanta The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018 |
| 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 |
| Dr ESHITA SINGH |
Medanta the Medicity Hospital |
Medanta The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018 Gurgaon HARYANA |
09902145542
hanakoeshi07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional 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, (2) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age of 18 years to 70 years of patients undergoing Right Lobe Living Donor Liver Transplant
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Age more than 70 years
Deceased Donor Liver Transplants
Combined Procedures (combined liver and cardiac bypass or combined liver and kidney transplant)
Retransplantations
Acute Liver Failure Patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the Incidence and Predictors of Post Reperfusion Syndrome in Living Donor Liver Transplantation |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of Early Allograft Dysfunction using Olthoff Criteria
Determine Early Allograft Dysfunction based on biopsy
Determine Acute Kidney Injury based on KDIGO criteria (Kidney disease : Improving global outcomes criteria)
Determine cardiac complications within first 7 postoperative days (arrhythmias, acute myocardial infarction, stroke, heart failure) as per Major Adverse Cardiac Events |
1 year |
|
|
Target Sample Size
|
Total Sample Size="163" Sample Size from India="163"
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)
|
07/03/2026 |
| 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="1" Months="0" 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
|
Liver transplantation represents one of the most complex and resource-intensive surgical interventions in modern medicine, undertaken in patients with advanced liver disease and significant hemodynamic compromise. Despite improvements in surgical techniques, anesthesia, and perioperative care, intraoperative and early postoperative complications remain major determinants of graft and patient survival. Among these, Post Reperfusion Syndrome (PRS) and Early Allograft Dysfunction (EAD) are of particular concern, as they directly influence hemodynamic stability, graft viability, and long-term outcomes Post Reperfusion Syndrome (PRS) and Early Allograft Dysfunction (EAD), though temporally distinct, are mechanistically intertwined. The hemodynamic instability, ischemia-reperfusion injury, and metabolic insults characteristic of PRS can compromise graft function, creating a substrate for EAD in the postoperative period. Understanding their shared and independent risk factors, pathophysiology, and implications is essential for improving patient optimisation, intraoperative management, and postoperative care in liver transplantation. In this study we will be evaluating the contribution of PRS on the functioning of the graft in the postoperative period to correlate intraoperative PRS with postoperative EAD, helping identify modifiable risk factors to improve patient outcomes. |