Tissue Microdialysis Monitoring of Liver Grafts

N/AEnrolling By InvitationNCT06890234

University Medical Centre Ljubljana25 enrolled

Overview

This study will investigate the dynamics of metabolic molecules sampled from human liver grafts during the early postoperative period using tissue microdialysis. The obtained tissue samples will be compared with standard liver function tests and dynamic functional liver assessment tests. The primary objective is to evaluate the clinical feasibility, utility, and non-inferiority of tissue microdialysis in comparison to current standard methods for monitoring liver grafts.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Transplantation Liver Graft Dysfunction Tissue Metabolism

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Adult patients aged between 18 and 65 years. * Liver transplant candidates on the Slovenian liver transplant waiting list, matched with an available liver graft through the Eurotransplant system, and scheduled for the surgical procedure. * Signed informed consent to participate in the microdialysis sampling research project, including consent to share the obtained samples with other research studies Exclusion criteria: * Patients under 18 or over 65 years of age. * Refusal to participate in the study. * Verbal withdrawal of consent at any point during the study, even if informed consent has been previously signed. * Surgical contraindications preventing the insertion of a microdialysis catheter into the liver graft during the procedure. * Surgical revision within 48 hours post-transplantation resulting in liver graft loss and removal. * History of allergic reactions to radiographic contrast media. * Death during the liver transplant procedure.

Locations (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia, Slovenia

Outcomes

Primary Outcomes

The agreement between microdialysis-derived metabolite levels and conventional liver function tests

The correlation between tissue microdialysis metabolites (glucose, pyruvate, lactate, glycerol, urea) and standard static and dynamic liver function tests (ALT, AST, bilirubin, INR, plasma lactate, plasma pyruvate, and indocyanine green \[ICG\] clearance) in the early post-transplant period.

Time frame: From the end of liver transplant surgery up to 5 days post-transplant

Data from ClinicalTrials.gov

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