The efficacy of Intravenous amino acids in reducing the occurrence of AKI after Live Donor Liver Transplant: An Open Label Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- ILBS
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the incidence of early post transplant AKI (within 1st week) in patients undergoing LDLT between L-amino acids infusion and standard treatment groups.
研究概览
简要总结
Acute Kidney Injury (AKI) remains a common and serious complication following live donor liver transplantation (LDLT), with incidence rates ranging upto 60%. AKI increases patient morbidity, hospital stay, need for renal replacement therapy, and mortality. Several risk factors contribute to post-transplant AKI, including intraoperative hemodynamic shifts, ischemia-reperfusion injury, and immunosuppressive nephrotoxicity. Emerging evidence suggests that perioperative administration of intravenous amino acids reduces the incidence of AKI by Increasing renal perfusion, renal oxygenation, and GFR.
This prospective, open-label, randomized controlled trial aims to evaluate the efficacy of intravenous amino acid infusion in reducing AKI after LDLT. Eligible adult patients undergoing LDLT will be randomized into two groups: one receiving Continuous infusion of a L-amino acids mixture in a dose of 2 g/kg dry body weight/day (to a maximum 100 g/day) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation, and the other receiving standard management. The primary outcome is the incidence of AKI as per KDIGO criteria within 7 days of transplant. Secondary outcomes include early graft dysfunction, need for renal replacement therapy, ICU and inhospital stay, and Major Morbidity. serum NGAL and cystatin C levels will be assessed as early AKI biomarker. The findings of this study will help establish whether amino acid infusion can be a cost-effective, safe, and easily implementable strategy for AKI prevention in liver transplant patients, thereby improving outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •All Living donor liver transplant recipient (LDLT) Recipient Signed informed consent.
排除标准
- •Negative consent.
- •Pediatric LDLT.
- •ALF patient undergoing LDLT.
- •Patients on intermittent or continuous renal replacement therapy.
- •Patients with eGFR less then 40 ml per min per 1.73 m
- •SLKT and prior Kidney transplant.
- •Patient has a hypersensitivity (known allergy) to one or more of the included amino acids.
- •Patient has a known congenital alteration of amino acid metabolism.
结局指标
主要结局
To compare the incidence of early post transplant AKI (within 1st week) in patients undergoing LDLT between L-amino acids infusion and standard treatment groups.
时间窗: within 1st week
次要结局
- To determine eGFR at Day 30 and 90 post transplant.(Day 90)
- The use and duration of kidney-replacement therapy during the hospital stay
- To Determine the severity of early post Liver transplant AKI(within 1st week)
- To determine the factors responsible for occurrence of early post-transplant AKI(within 1st week)
- In Hospital Mortality(1 month)
- The duration of mechanical ventilation, ICU stay and in hospital stay.(1 month)
- Major Morbidity (Clavien-Dindo more than equal to 3) and Early Graft Dysfunction(1 month)
研究者
Ravi Roshan
Institute of liver and biliary science
