| CTRI Number |
CTRI/2020/08/026979 [Registered on: 04/08/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reperfusion Syndrome in liver transplant |
|
Scientific Title of Study
|
Post Reperfusion Syndrome in living donor liver transplant: a prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta A Singh |
| Designation |
Director & Head Anaesthesiology and critical care Max CLBS |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital 1 Press Enclave Road Saket, first floor, OT Department Room-Anaesthesia Office
1 Press Enclave Road Saket,first floor, OT Department Room-Anaesthesia Office
South
DELHI
110070
India |
| Phone |
9810625177 |
| Fax |
|
| Email |
drshwetasingh29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta A Singh |
| Designation |
Director & Head Anaesthesiology and critical care Max CLBS |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital 1 Press Enclave Road Saket first floor, OT Department Room-Anaesthesia Office
1 Press Enclave Road Saket,first floor, OT Department Room-Anaesthesia Office
South
DELHI
110070
India |
| Phone |
9810625177 |
| Fax |
|
| Email |
drshwetasingh29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta A Singh |
| Designation |
Director & Head Anaesthesiology and critical care Max CLBS |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital 1 Press Enclave Road Saket first floor, OT Department Room-Anaesthesia Office
1 Press Enclave Road Saket first floor, OT Department Room-Anaesthesia Office
South
DELHI
110070
India |
| Phone |
9810625177 |
| Fax |
|
| Email |
drshwetasingh29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital 1 Press Enclave Road Saket first floor, OT Department Room-Anaesthesia Office |
|
|
Primary Sponsor
|
| Name |
Center for liver and Biliary Sciences Max Super Speciality Hospital SaketNew DelhiIndia |
| Address |
1 Press Enclave Road, 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 |
| Shweta A Singh |
Max Super Speciality Hospital, Saket West Block,1st Floor, OT department |
1 Press Enclave Road Saket first floor, OT Department Room-Anaesthesia Office
South
DELHI |
9810625177
drshwetasingh29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MaxHealthcareEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive LT procedures in adult patients in our unit will be enrolled for collection of data |
|
| ExclusionCriteria |
| Details |
1. All Deceased - donor related transplantation (DDLTs)
2. Liver transplants done in patients with ALF
3. LT for non-cirrhotic liver disease
4. Combined liver/kidney transplantation
5. Re-transplantation
6. All liver recipients identified to have cirrhotic cardiomyopathy, grade 3 Diastolic dysfunction on routine preoperative evaluation.
7. All LT recipients on Inotropes before surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document the incidence of PRS during LDLT and classify severity of PRS |
at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To identify the predictors of PRS. |
On Postoperative Day 30 or at discharge (whichever is first) |
| 2)To examine the postoperative consequences of PRS after LT |
On Postoperative Day 30 or at discharge (whichever is first) |
|
|
Target Sample Size
|
Total Sample Size="346"
Sample Size from India="346"
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)
|
04/08/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Liver transplant (LT) surgeries are associated with major intra-operative hemodynamic changes. One such major change occurs at the time of reperfusion of the new liver graft, when the newly anastomosed portal vein is unclamped to reperfuse the liver graft inside the recipient. It leads to influx of cold, acidic fluid from the liver graft into the recepient’s circulation which causes a major hemodynamic response. This has been called as postreperfusion syndrome (PRS). The incidence of PRS in deceased donor liver transplant (DDLT) surgeries is shown to be extremely variable varying between 8 - 50%. Since pro-inflammatory cytokines released from the cadaveric graft as well as the prolonged cold ischemia time due to delays in deceased donor programme contributeto PRS. We postulate, that the incidence of PRS to be lesser in Living donor liver transplant (LDLT) than in DDLT as in LDLT the quality of graft is optimal. The catecholamine storm of cadaveric donor is avoided.Also, the donor hepatectomy and transplant are simultaneously performed,hence anhepatic and cold ischemia times are reduced. We wish to document the occurrence of PRS in LDLT at our center.n We also wish to identify the predictors of PRS and the postoperative consequences of PRS on liver recepients. |