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CTRI Number  CTRI/2024/09/074465 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Studying the correlation between cumulative fluid balance (before surgery) and complications in patients presenting with acute liver failure after undergoing liver transplant 
Scientific Title of Study   Effect of positive cumulative fluid balance on post-operative complications in patients undergoing liver transplant for acute liver failure - A retrospective 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  Medhavi Saxena 
Designation  Senior Resident - PDCC  
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical Care, 3rd floor, Phase 2 building, Institute of Liver and Biliary Sciences
D-1, Vasant Kunj Road, Ghitorni, New Delhi
South
DELHI
110070
India 
Phone  9318324405  
Fax    
Email  medhavisaxena.28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Medhavi Saxena 
Designation  Senior Resident - PDCC  
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical Care, 3rd floor, Phase 2 building, Institute of Liver and Biliary Sciences
D-1, Vasant kunj road, Ghitorni, New Delhi
South
DELHI
110070
India 
Phone  9318324405  
Fax    
Email  medhavisaxena.28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Udit Dhingra 
Designation  Associate Professor 
Affiliation  Institute of Liver and Biliary Sciences, New Delhi 
Address  Department of Anesthesiology and Critical Care, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj Road, Ghitorni, New Delhi

South
DELHI
110070
India 
Phone  8861987684  
Fax    
Email  uddh1989@gmail.com  
 
Source of Monetary or Material Support  
Institute of Liver and Biliary Sciences, D-1, Vasant Kunj Road, Ghitorni, New Delhi -110070 Country : India 
 
Primary Sponsor  
Name  Institute of Liver and Biliary Sciences 
Address  D-1, Vasant Kunj Road, Ghitorni, New Delhi - 110070 
Type of Sponsor  Research institution and hospital 
 
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 Medhavi Saxena  Institute of Liver and Biliary Sciences  Department of Anaesthesiology and Critical Care, 3rd Floor, Phase 2 building, Vasant Kunj Road, Ghitorni, New Delhi - 110070
South
DELHI 
9318324405

medhavisaxena.28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K720||Acute and subacute hepatic failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil as it is an observational study 
Comparator Agent  Nil  Nil as it is an observational study  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients who underwent liver transplant at the ILBS for acute liver failure from January 2014 to July 2024 will be included in the study.  
 
ExclusionCriteria 
Details  Patients with incomplete records 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Length of ICU stay (in days)  At baseline (after shifting the patient to ICU after liver transplant surgery) 
 
Secondary Outcome  
Outcome  TimePoints 


Development of sepsis



 
Duration of stay in ICU after liver transplant surgery 
Development of renal, pulmonary & neurological complications after liver transplant.

 
Duration of stay in ICU after liver transplant surgery  
Number of days on mechanical ventilation
 
Duration of stay in ICU after liver transplant surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   07/10/2024 
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="0"
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  

Positive cumulative fluid balance (CFB) in patients undergoing surgery and in critically ill patients has been associated with increased morbidity and mortality. With respect to liver transplant (LT) surgery, there are periods of hemodynamic instability with significant blood loss, reperfusion phase-induced hypotension frequently requiring active resuscitation, and risk of systemic inflammatory response with endothelial leak and extravascular fluid shifts. CFB after LT puts patients at risk for several multi-organ system complications including prolonged intubation and oxygen requirement, interstitial edema with delayed wound healing, and bowel wall edema with impaired bowel function and prolonged receipt of IV fluids or parenteral nutrition, contributing to prolonged postoperative ICU and hospital length-of-stay. Intra-operative fluid management of patients undergoing LT for ALF differs from that of CLD due to the difference in etiology and absence of compensatory pathological changes present in CLD patients. Studies where the impact of positive cumulative fluid balance on post-operative outcomes after LT is studied, are mostly done on adult and pediatric patients who presented with end-stage liver disease. We aim to study the effect of pre-operative and intra-operative CFB, in patients (both adult and pediatric) undergoing LT for ALF, on post-operative outcomes. We will review records of all patients who underwent LT for ALF in the last 10 years at the ILBS and exclude the ones with incomplete records. We hypothesize that positive CFB in pre-operative and intra-operative periods leads to increased length of ICU stay and incidence of post-operative renal, pulmonary and neurological outcomes.

 
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