Effect of Perioperative Oral Rifaximin on Early Graft Dysfunction in Adult Living Donor Liver Transplant: An Open Label Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
研究概览
简要总结
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.
详细描述
Methodology:
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Study population: All patients undergoing adult living donor liver transplant recipients
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Study design: Open label Randomized control Study
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Study period: After ethical board clearance, all LDLT recipients satisfying inclusion criteria till June 2025
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Sample size: n=100
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Intervention: Preoperative Rifaximin supplementation 550 mg twice daily from preoperatively 2 weeks to post op POD 1 to 7
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Monitoring and assessment: Not valid
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Adverse effects: No adverse effect is expected to occur out of study protocols. except vomiting, headache, dizziness, nausea
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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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All recipients (adults) undergoing living donor liver transplant in ILBS.
排除标准
- •Negative consent
- •Hypersensitivity to Rifaximin
- •Patients undergoing retransplant
- •ALF, ACLF
- •Pediatrics patients
- •Patients on rifaximin
研究组 & 干预措施
Rifaximin+SOC
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.
干预措施: Rifaximin 550 MG (Drug)
Rifaximin+SOC
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.
干预措施: SOC (Other)
Non Rifaximin + SOC
SOC (Standard of care) means both group will recieve similar post of care which is standard protocol at ILBS.
干预措施: SOC (Other)
结局指标
主要结局
Perioperative oral rifaximin on early graft dysfunction in adult living donor liver transplant.
时间窗: 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) 1. T. Bilirubin \>10 2. Urea 3. INR \> 1.6 4. AST/ALT \> 2000
次要结局
- To evaluate the effect of rifaximin on early graft dysfunction(9 months)
- Ischemia reperfusion injury markers (Cathepsin G, CD 86)(9 months)
- EAD (IL6, IL17)(9 months)
- To study the effect of perioperative oral rifaximin on infectious complications, EGD related graft loss and in-hospital mortality.(9 months)