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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  
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 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  
Status 
Not Applicable 
 
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

 
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