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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All recipients (adults) undergoing living donor liver transplant in ILBS.

Disqualifiers

Negative consent

Hypersensitivity to Rifaximin

Patients undergoing retransplant

ALF, ACLF

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rifaximin 550 MG

    Drug

    Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7

  • SOC

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Rifaximin+SOCExperimental treatment 2 interventions
Group B: Non Rifaximin + SOCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.

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

Time frame
9 months

Secondary outcomes

1

To evaluate the effect of rifaximin on early graft dysfunction

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

Time frame
9 months
2

Ischemia reperfusion injury markers (Cathepsin G, CD 86)

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

Time frame
9 months
3

EAD (IL6, IL17)

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

Time frame
9 months
4

To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.

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

Time frame
9 months

Other outcomes

Sponsors and contacts

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