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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Drug: Rifaximin 550 MG; Other: SOC

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tapan Kumar Pradhan, MS; Phone Number: 9970189001; Email: tapan.ravi94@gmail.com
• Study Contact Backup: Name: Nilesh Sadashiv Patil, MCh; Phone Number: 01146300000; Email: dr.nils.p@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Insitute of Liver and Biliary Sciences
      • Contact: Tapan Kumar Pradhan, MS; Phone Number: 9970189001; Email: tapan.ravi94@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rifaximin+SOC; 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.	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.
Active Comparator: Non Rifaximin + SOC; SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.	The study aims to see the effect of peri-operative (before transplant and post transplant) rifaximin on early graft dysfunction. Preoperatively investigators will be giving Tab rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 while the other arm will not be given rifaximin. Early graft dysfunction is identified using modified altoff criteria, Pamecha et al. creteria(Early graft dysfunction in diseased donor liver transplant and living donor liver transplant); T. Bilirubin >10; Urea; INR > 1.6; AST/ALT > 2000	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of rifaximin on early graft dysfunction	Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting	9 months
Ischemia reperfusion injury markers (Cathepsin G, CD 86)	Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting	9 months
EAD (IL6, IL17)	Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting	9 months
To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.	Investigators will study the indirect markers for early graft dysfuntion which were recently discovered and the role of rifaximin on the markers. Investigators will do all this in the living donor liver transplant setting	9 months

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Anti-Bacterial Agents; Anti-Infective Agents; Gastrointestinal Agents; Rifaximin
• Other Study ID Numbers: ILBS-LDLT-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No