Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06743464

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

Led by Institute of Liver and Biliary Sciences, India · Updated on 2025-03-05

100

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effect of perioperative oral rifaximin on early graft dysfunction (EGD) in adults undergoing living donor liver transplant. EGD is a condition where the new liver graft shows poor function soon after transplantation, which can lead to higher risks of graft loss or death. Factors influencing EGD include graft size, injury during transplantation, recipient's metabolic needs, and blood flow to the graft. Previous studies showed that rifaximin, an antibiotic, reduced EGD by 50% in deceased donor liver transplants, but this study focuses on living donor liver transplants and uses rifaximin around the time of surgery. Participants will be randomly assigned to receive either rifaximin 550 mg twice daily starting two weeks before surgery through seven days after surgery along with standard post-operative care, or standard care alone without rifaximin. The study plans to enroll 100 adult living donor liver transplant recipients and will be conducted openly without blinding. Both groups will receive the same standard post-transplant care at the study center. During the study, participants will be monitored for early graft function and complications for nine months. Researchers will assess markers of ischemia reperfusion injury and inflammation, track infectious complications, graft loss related to EGD, and in-hospital mortality. The primary outcome is the effect of rifaximin on early graft dysfunction within nine months. Safety will be monitored, with expected side effects including possible vomiting, headache, dizziness, or nausea. The total study duration will cover preoperative treatment, surgery, and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All adult recipients undergoing living donor liver transplant at the Institute of Liver and Biliary Sciences
Not Eligible

You will not qualify if you...

  • Negative consent or refusal to participate
  • Known hypersensitivity to rifaximin
  • Patients undergoing liver retransplant
  • Patients with acute liver failure (ALF) or acute-on-chronic liver failure (ACLF)
  • Pediatric patients
  • Patients already taking rifaximin medication

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 3 weeks including 2 weeks preoperative and 1 week postoperative

Participants receive oral rifaximin supplementation twice daily starting 2 weeks before surgery and continuing from post-operative day 1 to day 7 alongside standard post-operative care.

Multiple visits during preoperative and post-operative periods

Follow-up

Duration - Up to 9 months

Participants are monitored for early graft dysfunction and other outcomes up to 9 months after treatment.

Visits scheduled as per standard post-transplant follow-up protocols

Trial Site Locations

Total: 1 location

1

Insitute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India, 110070

Actively Recruiting

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Research Team

T

Tapan Kumar Pradhan, MS

N

Nilesh Sadashiv Patil, MCh

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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