Blood-Bile Ratio Tacrolimus After Liver Transplantation

NCT ID: NCT03882164

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2020-05-31

Brief Summary

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.

Detailed Description

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

Conditions

Liver Transplant; Complications; Immunosuppression; Transplant Failure; Transplant; Complication, Rejection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Rejection

Patient undergone liver transplant with diagnosis of rejection within 10 days

Blood-Bile Ratio of Tacrolimus

Intervention Type: DIAGNOSTIC_TEST

Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

No-Rejection

Patient undergone liver transplant wothout diagnosis of rejection within 10 days

No interventions assigned to this group

Interventions

Blood-Bile Ratio of Tacrolimus

Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marco Maria Pascale

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marco Maria Pascale

Roma, RM, Italy

Countries

Italy

Other Identifiers

PoliclinicoUAG-LTU

Identifier Type: -

Identifier Source: org_study_id