| CTRI Number |
CTRI/2024/10/075683 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing two methods that measure heart function in patients undergoing liver transplantation surgery. |
|
Scientific Title of Study
|
Correlation of Cardiac Output measured by transpulmonary thermodilution versus Pulse Contour analysis in Liver transplant recipients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmi Kumar |
| Designation |
Professor and Head |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
914842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKshama Balakrishna |
| Designation |
Fellow Transplant Anaesthesia |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care
Tower 6 Floor 1
AIMS Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9900379769 |
| Fax |
914842852020 |
| Email |
kshama.db92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute Of Medical Sciences
Amrita lane Edapally
Kochi 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute Of Medical Sciences |
| Address |
Amrita Lane
Edapally
Kochi 682041 |
| Type of Sponsor |
Private medical college |
|
|
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 Lakshmi Kumar |
Amrita Institute Of Medical Sciences |
Department of Anaesthesia and Critical care
Tower 6 Floor 1 AIMS Kochi 682041
AIMS Kochi
Ernakulam
KERALA |
9496211333
914842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cardiac output derived by pulse contour analysis during specified times at liver transplant surgery |
Comparison of cardiac output using pulse contour using the same PiCCO catheter |
| Intervention |
Thermodilution derived cardiac output using a PiCCO catheter at specified times during liver tarnsplant surgery |
15 ml ice cold saline is injected through the central line and cardiac output measured by change in temperature recorded by a thermistor in
the femoral artery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients presenting for elective liver transplantation |
|
| ExclusionCriteria |
| Details |
Emergency transplants
Transplants for acute liver failure and acute on chronic liver failure
Multiorgan transplants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of cardiac output measured by PiCCO thermodilution versus pulse contour during liver transplant surgery |
Specified times during surgery
T0 baseline
T1 2 h in the dissection phase
T2 Anhepatic phase after portal vein shunt
T3 10 minutes after reperfusion
T4 Skin closure at the completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of Global end diastolic volume index versus central venous pressure
Extravascular lung water index versus oxygenation index |
At specified time points during surgery namely
T0 baseline
T1 2 h in the dissection phase
T2 Anhepatic phase after portal vein shunt
T3 10 minutes after reperfusion
T4 Skin closure at the end of surgery |
|
|
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)
|
14/11/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thermodilution and pulse contour are both the principles in PiCCO derived cardiac output.PiCCO is more reliable and also provides parameters of lung water and global end diastolic volume that correlate with the volume status and. are additional parameters The study aims to look at the correlation of cardiac output measured by thermodilution with the pulse contour method and at the accuracy of PiCCO parameters global end-diatolic volume index and extra vascular lung water index with static parameters like the CVP and the oxygenation index |