Clinical trial NCT06743464: Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant
Official title: Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \&amp; 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

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
timeFrame: 9 months
Secondary outcomes:
measure: To evaluate the effect of rifaximin on early graft dysfunction
timeFrame: 9 months
measure: Ischemia reperfusion injury markers (Cathepsin G, CD 86)
timeFrame: 9 months
measure: EAD (IL6, IL17)
timeFrame: 9 months
measure: To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.
timeFrame: 9 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Insitute of Liver and Biliary Sciences
state: Delhi
Study officials:
References: