| CTRI Number |
CTRI/2022/09/045448 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
27/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
to find out the parameter of heart ultrasound which can predict post reperfusion syndrome (complication that may develop during organ transplant) during liver transplant. |
|
Scientific Title of Study
|
Echo-cardiographic parameters to predict Post Reperfusion Syndrome during Living
Donor Liver Transplantation: 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 Vaishali Agarwal |
| Designation |
SeniorResident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anesthesia, Institute of liver and biliary sciences, Vasantkunj, Delhi
New Delhi
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
shagun30agarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
AssociateProfessor |
| Affiliation |
institute of liver and biliary sciences |
| Address |
Department of Anesthesia, Institute of liver and biliary sciences, Vasantkunj, Delhi
New Delhi
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Sindwani |
| Designation |
AssociateProfessor |
| Affiliation |
institute of liver and biliary sciences |
| Address |
Department of Anesthesia, Institute of liver and biliary sciences, Vasantkunj, Delhi
North East
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
|
Source of Monetary or Material Support
|
| institute of liver and biliary sciences
|
|
|
Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
Department of Anesthesia, Institute of liver and biliary sciences, Vasantkunj, Delhi
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vaishali Agarwal |
Institute of liver and biliary sciences |
Department of Anesthesia , vasantkunj, Delhi
New Delhi
DELHI |
8840661695
shagun30agarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Male |
| Details |
All patients undergoing LDLT |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients undergoing double transplant at same setting.
Patients with Acute Liver Failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| echocardiographic parameter to predict post reperfusion syndrome during living donor liver transplantation |
Baseline, Dissection phase, 10min peclampingof IVC, 10 min postclamping of IVC, Reperfusion, at biliary construction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| echocardiographic parameter to predict time to achieve hemodynamic stability |
Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2022 |
| Date of Study Completion (India) |
20/04/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients undergoing liver transplant frequently display considerable physiological changes during the procedures as a result of both the disease process and the surgery. Haemodynamic changes occurring during liver transplantation are severe and rapid. Eechocardiography is a non invasive monitor that provides information regarding dynamic function of heart, volume status, contractility, regional wall motion. Vital information which can be gathered from standard echocardiography views includes biventricular function, valvular function, volume status, pericardial abnormalities, intra-cardiac thrombus, pulmonary embolism, ventricular outflow obstruction, cardiac tamponade. As per our literature,echocardiographic parameters have never been studied to predict the post reperfusion syndrome during living donor liver transplantation. Hence, we are conducting this study to find the echocardiographic parameters which can predict the post reperfusion syndrome during living donor liver transplantation. |