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

Not Applicable

Not yet recruiting

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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Rifaximin+SOC	Rifaximin 550 MG	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.
Rifaximin+SOC	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.
Non Rifaximin + SOC	SOC	SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (1): Insitute of Liver and Biliary Sciences
🇮🇳
New Delhi, Delhi, India