| 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
|
|
|
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
|
|
|
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. |