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临床试验/NCT03882164
NCT03882164Unknown不适用

Use of Tacrolimus Blood-bile Ratio for the Detection of Early Liver Failure After Liver Transplantation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年2月21日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Marco Maria Pascale

Resident

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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