Tissue Microdialysis Monitoring of Liver Grafts

• Conditions: Liver Transplantation; Liver Graft Dysfunction; Tissue Metabolism

• Registration Number: NCT06890234
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-11
• Status Verified: 2025-01
• Study First Submitted: 2025-03-16
• Study First Submitted QC: 2025-03-16
• Last Update Submitted: 2025-03-16
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The agreement between microdialysis-derived metabolite levels and conventional liver function tests	From the end of liver transplant surgery up to 5 days post-transplant	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.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia