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

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: Chronic Liver Disease

Treatments: Other: SOC; Drug: Rifaximin 550 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06743464

ILBS-LDLT-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Negative consent

  • Hypersensitivity to Rifaximin
  • Patients undergoing retransplant
  • ALF, ACLF
  • Pediatrics patients
  • Patients on rifaximin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rifaximin+SOC

Experimental group

Description:

Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS.

Treatment:

Drug: Rifaximin 550 MG

Other: SOC

Non Rifaximin + SOC

Active Comparator group

Description:

SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS.

Treatment:

Other: SOC