CTRI Number |
CTRI/2022/03/041168 [Registered on: 17/03/2022] Trial Registered Prospectively |
Last Modified On: |
04/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
To find out echocardiographic (use of ultrasound to investigate the actions of heart) parameter to say which can develop post reperfusion syndrome (complication that may develop during organ transplant) during liver transplant.
|
Scientific Title of Study
|
Intraoperative Transesophageal 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 |
Senior Resident |
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 |
8840661695 |
Fax |
|
Email |
shagun30agarwal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gaurav Sindwani |
Designation |
Associate Professor |
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 |
8728089898 |
Fax |
|
Email |
drsindwani25@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vaishali Agarwal |
Designation |
Senior Resident |
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 |
8840661695 |
Fax |
|
Email |
shagun30agarwal@gmail.com |
|
Source of Monetary or Material Support
|
Institute of liver and biliary sciences |
|
Primary Sponsor
|
Name |
Institute of liver and biliary sciences |
Address |
Vasantkunj, 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, Institute of liver and biliary sciences, Vasantkunj 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, (2) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
All patients undergoing LDLT in whom transesophageal echocardiography probe will be inserted
Age > 18 years |
|
ExclusionCriteria |
Details |
Patient refusal
Patients undergoing double transplant at same setting.
Patients with Acute Liver Failure
Previous history of oesophageal pathology (esophageal stricture, cancer, diverticulum, laceration, > grade 3 oesophageal varices, Gastric varices, active esophagitis) or recent esophageal surgery.
History of recent (< 1 month) upper gastro-intestinal bleed. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Transesophageal echocardiographic parameter to predict post reperfusion syndrome during living donor liver transplantation |
Baseline after induction
10 minutes after reperfusion
After abdominal closure |
|
Secondary Outcome
|
Outcome |
TimePoints |
Transesophageal echocardiographic parameter to predict time to achieve hemodynamic stability |
Baseline after induction
10 minutes after reperfusion
After abdominal closure |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
24/03/2022 |
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="6" 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
|
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. Transoesophageal echocardiography is a minimally invasive monitor that provides real-time visual information regarding dynamic function of heart, volume status, contractility, regional wall motion. Intraoperative transoesophageal echocardiography has been standard practice for cardiac surgical procedures for more than 2 decades but its use during liver transplant is gaining popularity in recent years. Society for advancement of transplant anesthesia suggests, that transoesophageal echocardiography use in liver transplant recipients is effective and safe.1 Vital information which can be gathered from standard transoesophageal 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 search, intraoperative transesophageal 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 intraoperative transesophageal echocardiographic parameters which can predict the post reperfusion syndrome during living donor liver transplantation. |