Use of Tacrolimus Blood-bile Ratio for the Detection of Early Liver Failure After Liver Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Analysis of early liver rejection
研究概览
简要总结
Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule is rapidly absorbed after oral administration (maximum plasma concentration after 1-2 hours), is found in the circulation bound mainly to erythrocytes and, after being metabolized by CYP3A4, is eliminated through the bile. The importance of the tacrolimus blood dosage is now widely recognized for detecting the immunosuppressive capacity reached in the individual patient or the eventual overdose of the drug. In the use of Tacrolimus after Liver Transplantation, however, it is interesting to note that the biochemical pathway for metabolism and excretion of the drug is present in the transplanted organ, the main object of immunological and functional surveillance. The excretory capacity of Tacrolimus by the liver through the bile, therefore, could be a useful tool for recognizing the early liver failure from a functional point of view, before the onset of hepatoecrosis.
详细描述
Prospective monocentric randomized study comparing two parallel groups:
liver transplanted patients with early (10 POD) organ rejection (experimental arm); liver transplanted patients without early (10 POD) organ rejection (control arm) Primary Objective: Evaluation of a correlation between the reduction of Tacrolimus biliary excretion and the early liver failure Primary Endpoint: Increase of Tacrolimus blood-bile ratio measured before the onset of laboratory hepatonecrosis Secondary Objective: Analysis of the cause of any drug-related toxicity Secondary Endpoint: correlation study between drug dosage and biliary excretion level in case of blood overdose or clinical evidence of pharmacological toxicity
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age ≥18 years
- •History of recent liver transplant (less than 10 days)
- •Placement of kehr tube in the biliary tract during liver transplant
- •Immunosuppressive therapy with Tacrolimus
- •Functioning of kehr tube
排除标准
- •Age - Age ≥18 years
- •History of liver transplant for more than 10 days
- •Liver transplant without positioning of kehr tube
- •Immunosuppressive therapy with a drug different from Tacrolimus
- •No functioning of kehr tube18 years
- •History of liver transplant for more than 10 days
- •Liver transplant without positioning of kehr tube
- •Immunosuppressive therapy with a drug different from Tacrolimus
- •No functioning of kehr tube
结局指标
主要结局
Analysis of early liver rejection
时间窗: 10 days
Evaluation of early liver rejection throught creation of a Tacrolimus blood-bile ratio
次要结局
- Analysis of Tacrolimus toxicity(10 days)
研究者
Dr. Marco Maria Pascale
Resident
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
