Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant

Last updated: March 4, 2025
Sponsor: Institute of Liver and Biliary Sciences, India
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis C; Chronic

Hepatic Fibrosis

Primary Biliary Cholangitis

Treatment

SOC

Rifaximin 550 MG

Clinical Study ID

NCT06743464
ILBS-LDLT-03
  • Ages > 18
  • All Genders

Study Summary

Liver transplantation has been a lifesaving treatment for individuals with end stage liver disease and acute liver failure. However, initial poor function of a liver allograft after liver transplantation, termed early graft dysfunction (EGD), has been associated with increased allograft loss or mortality after transplantation. EGD in LDLT is multifactorial. Factors affecting EGD are GRWR, ischemia reperfusion injury, recipient metabolic demand, graft quality, graft inflow and outflow. Studies shows that the incidence of EGD is 15-38%. It is associated with increased allograft loss & mortality. Rifaximin is an antibiotic that reduces EGD by 50% as shown by 2 studies but this study was done in DDLT setting and rifaximin was given in the pretransplant group.

In this investigators will study the effect of perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All recipients (adults) undergoing living donor liver transplant in ILBS.

Exclusion

Exclusion Criteria:

  • Negative consent

  • Hypersensitivity to Rifaximin

  • Patients undergoing retransplant

  • ALF, ACLF

  • Pediatrics patients

  • Patients on rifaximin

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: SOC
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Methodology:

  • Study population: All patients undergoing adult living donor liver transplant recipients

  • Study design: Open label Randomized control Study

  • Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025

  • Sample size: n=100

    • Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7

    • Monitoring and assessment: Not valid

    • Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea

    • Stopping rule Not valid (b) Expected outcome of the project: Perioperative oral rifaximin decreases early allograft dysfunction in recipients of adult living donor liver transplant. (c) Ethical issues in the study and plans to address these issues: None expected

Connect with a study center

  • Insitute of Liver and Biliary Sciences

    New Delhi, Delhi 110070
    India

    Active - Recruiting

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