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CTRI Number  CTRI/2019/02/017587 [Registered on: 12/02/2019] Trial Registered Prospectively
Last Modified On: 09/02/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Effect of type of Liver lobe graft on Intraoperative haemodynamics and Recovery of the recipients after adult living donor Liver Transplantation 
Scientific Title of Study   Comparison of intra-operative haemodynamics and post-operative recovery of recipients in between the right and left liver lobe grafts after adult living donor liver transplantation – An observational 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 Gaurav Sindwani 
Designation  Assistant Professor 
Affiliation  ILBS 
Address  Department of Anaesthesia Fourth floor ILBS Hospital D-1, Vasant Kunj New Delhi

New Delhi
DELHI
110070
India 
Phone  918728089898  
Fax    
Email  drsindwani25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav Sindwani 
Designation  Assistant Professor 
Affiliation  ILBS 
Address  Department of Anaesthesia Fourth floor ILBS Hospital D-1, Vasant Kunj New Delhi

New Delhi
DELHI
110070
India 
Phone  918728089898  
Fax    
Email  drsindwani25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gaurav Sindwani 
Designation  Assistant Professor 
Affiliation  ILBS 
Address  Department of Anaesthesia Fourth floor ILBS Hospital D-1, Vasant Kunj New Delhi

New Delhi
DELHI
110070
India 
Phone  918728089898  
Fax    
Email  drsindwani25@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Fourth floor ILBS Hospital D-1, Vasant Kunj New Delhi 
 
Primary Sponsor  
Name  Gaurav Sndwani 
Address  Department of anaesthesia, ILBS hospital, New Delhi, 110070 
Type of Sponsor  Other [Deemed university] 
 
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 Gaurav Sindwani  ILBS Hospital  Department of Anaesthesia Fourth floor ILBS Hospital D-1, Vasant Kunj New Delhi
New Delhi
DELHI 
8728089898

drsindwani25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ILBS Institutiona ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K740||Hepatic fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1  group 1 includes 15 patients of right liver lobe undergoing adult living donor liver transplantation under general anaesthesia All patients will be given anaesthesia using standard institutional protocol. Inj noradrenaline at 0.1µg/kg/min or inj vasopressin 0.01U/min i.v will be started. Further their doses will be adjusted to maintain a mean arterial pressure of more than 60 mm of Hg. Haemodynamics and all inotropic drugs dosage will be noted immediately before unclamping of portal vein. After reperfusion inj phenylephrine 100 µg/ml and inj adrenaline 100 µg/ml boluses will be given to maintain the haemodynamic stability. Dosages of all drugs used during reperfusion will be noted. Further, noradrenaline dose will be adjusted to maintain mean arterial blood pressure of more than 60 mm Hg. Post reperfusion haemodynamics will be noted every 12 seconds until the haemodynamics becomes stable. Ongoing dose of inotropic drugs will be noted every hour until the inotropes are tapered. After shifting the patient to liver transplant ICU all inotropic drugs will be tapered off slowly with the target to maintain mean arterial pressure of more than 60 mm Hg. Total duration of noradrenaline, vasopressin and adrenaline infusion will be noted. Patients will be electively ventilated for 8-10 h. Extubation will be done after patients will be awake and responsive, the usual criteria for extubation will be: hemodynamic stability, normal graft functioning, normothermia, sufficient tidal volume (5–8 ml/kg), respiratory rate of less than 20 breaths/min, adequate minute ventilation, and positive gag reflexes. After tracheal extubation, oxygen was given by venturii mask in the ICU in order to maintain SaO292%. Changes in liver function tests for 7 days after transplant will be noted. Total duration of mechanical ventilation, number of days of ICU stay and any other complication will also be noted.  
Comparator Agent  Group 2  group 2 includes 15 patients of left liver lobe undergoing adult living donor liver transplantation under general anaesthesia All patients will be given anaesthesia using standard institutional protocol. Inj noradrenaline at 0.1µg/kg/min or inj vasopressin 0.01U/min i.v will be started. Further their doses will be adjusted to maintain a mean arterial pressure of more than 60 mm of Hg. Haemodynamics and all inotropic drugs dosage will be noted immediately before unclamping of portal vein. After reperfusion inj phenylephrine 100 µg/ml and inj adrenaline 100 µg/ml boluses will be given to maintain the haemodynamic stability. Dosages of all drugs used during reperfusion will be noted. Further, noradrenaline dose will be adjusted to maintain mean arterial blood pressure of more than 60 mm Hg. Post reperfusion haemodynamics will be noted every 12 seconds until the haemodynamics becomes stable. Ongoing dose of inotropic drugs will be noted every hour until the inotropes are tapered. After shifting the patient to liver transplant ICU all inotropic drugs will be tapered off slowly with the target to maintain mean arterial pressure of more than 60 mm Hg. Total duration of noradrenaline, vasopressin and adrenaline infusion will be noted. Patients will be electively ventilated for 8-10 h. Extubation will be done after patients will be awake and responsive, the usual criteria for extubation will be: hemodynamic stability, normal graft functioning, normothermia, sufficient tidal volume (5–8 ml/kg), respiratory rate of less than 20 breaths/min, adequate minute ventilation, and positive gag reflexes. After tracheal extubation, oxygen was given by venturii mask in the ICU in order to maintain SaO292%. Changes in liver function tests for 7 days after transplant will be noted. Total duration of mechanical ventilation, number of days of ICU stay and any other complication will also be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  To compare the dose and duration of inotropic drugs required to maintain the haemodynamic stability in between the right and left liver lobe grafts after adult living donor liver transplantation 
 
ExclusionCriteria 
Details  To compare the duration of invasive mechanical ventilation in between the two groups
To compare the duration of ICU stay in between the two groups
To compare the recovery of liver function tests in between the two groups
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the dose and duration of inotropic drugs required to maintain the haemodynamic stability in between the right and left liver lobe grafts after adult living donor liver transplantation

 
start of surgery til 7 days post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of invasive mechanical ventilation in between the two groups
To compare the duration of ICU stay in between the two groups
To compare the recovery of liver function tests in between the two groups
 
start of surgery til 7 days post operatively 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   21/02/2019 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Liver transplantation is one of the most challenging surgery for an anaesthetist. It is associated with marked haemodynamic changes which are seen maximally immediately after unclamping of the portal vein and reperfusion. One of the important haemodynamic changes is the post reperfusion syndrome (PRS). It has been defined by two different definitions. First definition was given by aggarwal et al which defined PRS as more than 30 % fall in B.P and H.R from baseline within 5 min of reperfusion for more than 1 min. Other definition was given by hilmi et al which describes PRS as mild and significant. Mild PRS is defined as a decrease of MAP and/or heart rate (HR) not reaching 30% of baseline value, lasting for less than 5 min, and responsive to an intravenous bolus dose of Calcium Chloride (1 g) and/or epinephrine (≤ 100 mcg) without the need to start a continuous infusion of vasopressors. On the other hand significant PRS was defined as a greater hemodynamic instability, a drop in MAP/HR exceeding 30% of baseline, asystole or hemodynamically significant arrhythmias; or the need to start the infusion of vasopressors during the intraoperative period and to continue throughout the postoperative period. Other presentations of significant PRS include a prolonged (defined as lasting more than 30 min) or recurrent (defined as reappearing within 30 min after resolution) fibrinolysis that requires treatment with antifibrinolytic agents. In adult living donor liver transplantation either left or right liver lobe is used as a graft depending upon the graft recipient weight ratio (GRWR) or residual liver volume in donor. Right lobe donors are associated with higher complications in donors when compared to left lobe donors. On the other hand left lobe donors have more complications in recipient when compared to right liver lobe. Haemodynamic changes after graft implantation can be affected by various factors like donor age, severity of liver and kidney disease, cold ischemia time, left ventricular dysfunction and surgical technique. However as per our literature search effect of liver lobe selection on the haemodynamic changes after reperfusion and on recipient recovery after liver transplantation have not been studied. Hence this study aims to compare the intra-operative haemodynamics and post-operative recovery of recipients in between the right and left liver lobe grafts after living donor liver transplantation.

 
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