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

NCT06743464 | Recruiting

• 1 other identifier: ILBS-LDLT-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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) 1. T. Bilirubin \>10 2. Urea 3. INR \> 1.6 4. AST/ALT \> 2000

  9 months

Secondary Outcomes (4)

• To evaluate the effect of rifaximin on early graft dysfunction

  9 months

• Ischemia reperfusion injury markers (Cathepsin G, CD 86)

  9 months

• EAD (IL6, IL17)

  9 months

• To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.

  9 months

Study Arms (2)

Rifaximin+SOC

EXPERIMENTAL

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; Other: SOC

Non Rifaximin + SOC

ACTIVE COMPARATOR

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

Other: SOC

Interventions

Rifaximin 550 MG DRUG

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

Rifaximin+SOC

SOC OTHER

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.

Non Rifaximin + SOC; Rifaximin+SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Insitute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Tapan Kumar Pradhan, MS

CONTACT

9970189001; tapan.ravi94@gmail.com

Nilesh Sadashiv Patil, MCh

CONTACT

01146300000; dr.nils.p@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 20, 2024
• Study Start: December 1, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2024-11

Locations

IN (1)