Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
Study Overview
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.
Detailed Description
Methodology:
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Study population: All patients undergoing adult living donor liver transplant recipients
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Study design: Open label Randomized control Study
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Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025
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Sample size: n=100
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Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
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Monitoring and assessment: Not valid
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Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea
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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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Rifaximin 550 MG (Drug)
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.
Intervention: SOC (Other)
Non Rifaximin + SOC
SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS.
Intervention: SOC (Other)
Outcomes
Primary Outcomes
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
Time Frame: 9 months
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
Secondary Outcomes
- 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)