Insitute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Location status: Recruiting
Recruiting
NCT Number: NCT06743464
Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Rifaximin 550 MG
DrugPreoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
SOC
OtherSOC 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 outcomes
-
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
Time frame: 9 months
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)
- T. Bilirubin >10
- Urea
- INR > 1.6
- AST/ALT > 2000
Secondary outcomes
-
To evaluate the effect of rifaximin on early graft dysfunction
Time frame: 9 months
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
-
Ischemia reperfusion injury markers (Cathepsin G, CD 86)
Time frame: 9 months
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
-
EAD (IL6, IL17)
Time frame: 9 months
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
-
To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.
Time frame: 9 months
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
Study contacts
Contact information is provided by the study sponsor or research team.
Nilesh Sadashiv Patil, MCh
CONTACT
Tapan Kumar Pradhan, MS
CONTACT
Sponsors and collaborators
Lead sponsor
Institute of Liver and Biliary Sciences, India
Other
Registry information
Official study title
Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Dec 20, 2024
- Registry last updated
- Mar 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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