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
|
|
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
|
|
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. |