Chronic Liver Disease
Conditions
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: * 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
Interventions
DRUGRifaximin 550 MG
Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
OTHERSOC
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.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant. | 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of rifaximin on early graft dysfunction | 9 months | 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 |
| Ischemia reperfusion injury markers (Cathepsin G, CD 86) | 9 months | 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 |
| EAD (IL6, IL17) | 9 months | 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 |
| To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality. | 9 months | 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 |
Countries
India
Contacts
Primary ContactTapan Kumar Pradhan, MS
Backup ContactNilesh Sadashiv Patil, MCh
Outcome results
None listed