Blood-Bile Ratio Tacrolimus After Liver Transplantation

NCT03882164 | Unknown FDA Drug

• 1 other identifier: PoliclinicoUAG-LTU
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Liver transplant;; Immunosuppression;; Transplant rejection;

Outcome Measures

Primary Outcomes (1)

• Analysis of early liver rejection

  Evaluation of early liver rejection throught creation of a Tacrolimus blood-bile ratio

  10 days

Secondary Outcomes (1)

• Analysis of Tacrolimus toxicity

  10 days

Study Arms (2)

Rejection

Patient undergone liver transplant with diagnosis of rejection within 10 days

Diagnostic Test: Blood-Bile Ratio of Tacrolimus

No-Rejection

Patient undergone liver transplant wothout diagnosis of rejection within 10 days

Interventions

Blood-Bile Ratio of Tacrolimus DIAGNOSTIC_TEST

Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

Rejection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergone liver transplant with positioning of Kehr tube

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Marco Maria Pascale

Roma, RM, 00167, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood; Bile

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 20, 2019
• Study Start: February 21, 2019
• Primary Completion: July 1, 2019
• Study Completion: May 1, 2020
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)