NCT06743464

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

Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	Rifaximin 550 MG	Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
OTHER	SOC	SOC means Standard of care which means that the patient will revieve standard post op care followed at our insitute and other hospitals in India.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-10
• Completion: 2025-12-31
• First posted: 2024-12-20
• Last updated: 2025-03-05

Locations

1 site across 1 country: India