Skip to main content
Clinical Trials/CTRI/2024/09/074465
CTRI/2024/09/074465
Not yet recruiting
Not Applicable

Effect of positive cumulative fluid balance on post-operative complications in patients undergoing liver transplant for acute liver failure - A retrospective observational study

Institute of Liver and Biliary Sciences1 site in 1 country80 target enrollmentStarted: October 7, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Locations
1
Primary Endpoint
Length of ICU stay (in days)

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Patients with incomplete records.

Outcomes

Primary Outcomes

Length of ICU stay (in days)

Time Frame: At baseline (after shifting the patient to ICU after liver transplant surgery)

Secondary Outcomes

  • Development of renal, pulmonary & neurological complications after liver transplant.
  • Number of days on mechanical ventilation

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Medhavi Saxena

Institute of Liver and Biliary Sciences, New Delhi

Study Sites (1)

Loading locations...

Similar Trials