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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin+SOC | Experimental | Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS. |
|
| Non Rifaximin + SOC | Active Comparator | SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin 550 MG | Drug | Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months |
| Ischemia reperfusion injury markers (Cathepsin G, CD 86) |
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Inclusion Criteria:
Exclusion Criteria:
Negative consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tapan Kumar Pradhan, MS | Contact | 9970189001 | tapan.ravi94@gmail.com | |
| Nilesh Sadashiv Patil, MCh | Contact | 01146300000 | dr.nils.p@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitute of Liver and Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| SOC | Other | 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. |
|
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 |
| 9 months |
| 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 | 9 months |
| 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 | 9 months |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |