| CTRI Number |
CTRI/2024/11/076244 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
delta lactate for monitoring liver graft function in post liver transplantations patients |
|
Scientific Title of Study
|
utility of delta lactate for predicting early allograft dysfunction in adult patients undergoing liver transplantations- A prospective observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elavarasan |
| Designation |
Fellow in Liver transplantation and critical care |
| Affiliation |
Dr Rela institute and medical center |
| Address |
third floor
liver transplant intensive care Unit
Dr Rela institute and medical center
7,CLC works road,
chromepet
chennai third floor
liver transplant intensive care Unit
Dr Rela institute and medical center
7,CLC works road,
chromepet
chennai Kancheepuram TAMIL NADU 600044 India |
| Phone |
8667694983 |
| Fax |
|
| Email |
elavarsanakash@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akila Rajakumar |
| Designation |
senior consultant and clinical lead- liver intensive care |
| Affiliation |
Dr Rela institute and medical center |
| Address |
third floor
liver transplant intensive care Unit
Dr Rela institute and medical center
7,CLC work road
chromepet
chennai third floor
liver transplant intensive care Unit
Dr Rela institute and medical center
7,CLC works road,
chromepet
chennai Kancheepuram TAMIL NADU 600044 India |
| Phone |
9840136295 |
| Fax |
|
| Email |
Akila.Rajakumar@relainstitute.com |
|
Details of Contact Person Public Query
|
| Name |
Elavarasan |
| Designation |
Fellow in Liver transplantation and critical care |
| Affiliation |
Dr Rela institute and medical center |
| Address |
third floor
liver transplant intensive care Unit
Dr Rela institute and medical center
7, CLC works road
chromepet
chennai third floor
liver transplant intensive care Unit
Dr Rela institute and medical center
7,CLC works road,
chromepet
chennai Kancheepuram TAMIL NADU 600044 India |
| Phone |
8667694983 |
| Fax |
|
| Email |
elavarsanakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rela institute and medical center
7, CLC works road
chrompet-600044
chennai
Tamil nadu
India |
|
|
Primary Sponsor
|
| Name |
Department of Liver anaesthesia and critical care |
| Address |
Dr Rela institute and medical center
7, CLC works road
chrompet- 600044
chennai
Tamil nadu |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Elavarasan |
Dr Rela institute and medical centre |
Department of Liver anaesthesia and critical care, Third floor, Dr Rela institute and medical center, no.7, CLC works road, chromepet, chennai Kancheepuram TAMIL NADU |
8667694983
elavarsanakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rela institute and medical center,Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged between 18-65 years who are undergoing living donor liver transplantation at our institution.
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years Patient refusal Diagnosed with infections like Empyema, spontaneous bacterial peritonitis intra-operatively AKI within 7 days prior to transplant, in the preoperative period Patient posted for re-exploration/surgery within POD 2. Patient on CRRT – intra op and post operative |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in lactate over 12 hours (delta lactate 0-12) as an early marker for early allograft dysfunction in Living donor liver transplant recipient (LDLTR) in early post-op period |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in lactate over 6 hours (delta lactate 0-6) and 24 hours (delta lactate 0-24) as markers for early allograft dysfunction in LDLTR in the early postoperative period. To examine the association between delta lactate levels and postoperative incidence of sepsis, AKI, prolonged mechanical ventilation, and biliary complications. To examine the association between delta lactate levels and length of hospital stay, ICU stay, and 30-day and 90-day mortality rates |
from POD - 0 to discharge from hospital, with 30 day and 90 day mortality |
|
|
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)
|
20/11/2024 |
| 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="0" 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
|
Liver
transplantation (LT) is the definitive treatment for patients with end-stage
liver disease
The
postoperative course following LT can be complicated by a variety of graft
dysfunctions, ranging from Early Allograft dysfunction (EAD) to primary
non-function of the liver graft
EAD has been shown to have a negative impact
on early postoperative complications such as Acute kidney injury (AKI), Sepsis,
biliary issues leading to prolonged ICU and hospital stay and, in some
instances, decreased patient survival
Lactate is a metabolite produced from
pyruvate by the enzyme lactate dehydrogenase (LDH), which is involved in
glycolysis during normal metabolism and exercise
Under
physiological conditions, approximately 1500 mmol of lactate is produced daily
and metabolized predominantly in the liver (approximately 60 %), kidneys
(approximately 30 %), and other organs
Reduction in lactate levels,
improvement in core temperature and improvement in urine output were considered
early signs of good allograft function
Lactate clearance after transplantation is
also considered a good surrogate marker of liver graft function. This
association has also been demonstrated in previous studies
Hyperlactatemia
at the end of liver resection surgery was an independent risk factor for
postoperative morbidity
Static lactate values in the immediate
postoperative period after LT have been established as useful markers for
increased hospital stay and ICU mortality.
In
contrast, dynamic indices of lactate metabolism, which measure the magnitude of
change over time, should be more useful in predicting outcomes. Hence, we
conducted a study to evaluate the decrease in lactate over time and its
association with graft dysfunction
Intraoperative lactate levels will
be checked every 1-2 hours, including immediately after reperfusion of the
liver graft. After admission to the ICU after LT, lactate levels will be checked
every 2nd hourly till it is less than 2 mmol/L and 4th hourly thereafter for 24
hours and then daily till discharge from the ICU. Lactate clearance [delta
lactate, that is, ∆ lactate] will be calculated as the reduction rate of
lactate between the time of reperfusion and admission to the ICU as follows:
∆
lactate0-12 = [Lactate at 30 minutes after reperfusion – Lactate at 12 hrs
after reperfusion]
Lactate
level at 30 minutes after reperfusion
Continuous variables are expressed
as medians with interquartile ranges, and categorical data are presented as
percentages, as appropriate. Continuous variables will be compared using the
Mann–Whitney U test, and categorical variables will be compared using the
chi-squared test or Fisher’s exact test. Receiver operating characteristic
(ROC) curves will be used to examine the accuracy of lactate. Statistical
analyses were performed using IBM SPSS for Windows version 20.0 (Armonk, NY,
USA |