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Recruiting NCT06743464

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

No phase Interventional Chronic Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rifaximin 550 MG, SOC.
Who it may be relevant to
Registry conditions: Chronic Liver Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial

Overview

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

  • Drug Rifaximin 550 MG
    Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
  • Other SOC
    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.

Primary outcome measures

  • Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant. [Time frame: 9 months]
Secondary outcome measures (4)
  • To evaluate the effect of rifaximin on early graft dysfunction [Time frame: 9 months]
  • Ischemia reperfusion injury markers (Cathepsin G, CD 86) [Time frame: 9 months]
  • EAD (IL6, IL17) [Time frame: 9 months]
  • To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality. [Time frame: 9 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Insitute of Liver and Biliary Sciences — New Delhi

Identifiers

NCT: NCT06743464 · ILBS-LDLT-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗