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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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 functionvalvular functionvolume statuspericardial abnormalitiesintra-cardiac thrombuspulmonary embolismventricular outflow obstructioncardiac 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.

 
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