Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- All adult recipients undergoing living donor liver transplant at the Institute of Liver and Biliary Sciences
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
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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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