| CTRI Number |
CTRI/2022/05/042416 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of post reperfusion syndrome and factors affecting it in patients undergoing Living donor liver transplantation. |
|
Scientific Title of Study
|
Incidence of post reperfusion syndrome(PRS) during living donor liver transplantation and factors affecting PRS." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Srivastava |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of anesthesia
Institute of liver and biliary sciences.
South
DELHI
110070
India |
| Phone |
9451665199 |
| Fax |
|
| Email |
Nidhi.capricon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Sindwani |
| Designation |
Associate proffessor |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of anesthesia
Institute of liver and biliary sciences,Vasant kunj.
South
DELHI
1100709
India |
| Phone |
8728089898 |
| Fax |
|
| Email |
drsindwani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Srivastava |
| Designation |
Senior resident |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of anesthesia
Institute of liver and biliary sciences
South
DELHI
110070
India |
| Phone |
9451665199 |
| Fax |
|
| Email |
Nidhi.capricon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of liver and biliary sciences,New delhi. |
|
|
Primary Sponsor
|
| Name |
Institute of livr and biliary sciences |
| Address |
Vasant kunj 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 |
| Nidhi Srivastava |
Institute of liver and biliary sciences. |
Department of Anesthesia
Fourth floor OT complex.
South
DELHI |
9451665199
nidhi.capricon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K743||Primary biliary cirrhosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients undergoing living donor liver
transplant
2. Age>18yrs. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients undergoing double transplant
Age <18yrs
Acute liver failure patient.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of post reperfusion syndrome in living donor liver transplant patients and factors which can predict it. |
Intraoperatively during reperfusion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic changes occuring immediately after release of portal vein clamp and factors affecting reperfusion syndrome. |
during reperfusion. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/05/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
Liver transplantation is the most challenging surgery
for an anaesthetist as severe and rapid haemodynamic changes can occur during
liver transplantation as
a result of both the disease process and the surgery.Post-reperfusion
syndrome (PRS) is a serious intraoperative complication of liver transplantations,
which typically appears after portal vein declamping and
can be associated with major cardiovascular and metabolic derangements. There are two definitions of PRS- Aggarwal1 defined PRS as a decrease in mean arterial pressure
(MAP) of more than 30% from the baseline value, for at least 1 min, occurring
during the first 5 min after reperfusion of the liver graft.
Hilmi et al2 has
stratified PRS into mild and moderate.
Mild
PRS-defined by a decrease of MAP and/or heart rate (HR) not reaching 30% of
baseline value, lasting for < 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.Significant PRS,
defined by 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.Risk factor
associated with PRS include-Hyperkalemia, Hypothermia immediately after
reperfusion, Advanced age of donors, Graft Weight, Volume of transfused blood
components, Cold ischaemia time , Warm ischaemia time, MELD score, Hypocalcemia,
Hypovolemia
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.
As per our literature search, there are no original studies evaluating post-reperfusion
syndrome in Living donor liver transplantation. Previous studies have included
only the deceased donor patients and the classical definition by Aggarwal and
hilmi have also been defined for the Deceased donor patients. Hence this study aimed to study the incidence
and factors which can affect PRS during living donor liver transplantation. |