Tissue Microdialysis Monitoring of Liver Grafts

NCT06890234 | Enrolling By Invitation

• 3 other identifiers: 0120-505/2023/3TP20230129TP20240197
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Liver Graft Dysfunction; Tissue Metabolism

Keywords

microdialysis; liver graft monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Adult patients (≥18 years old) who have undergone orthotopic liver transplantation

Eligibility Criteria

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

Study Population

Liver transplant candidates satisfying the inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Interstitial molecules in liver tissue with a molecular weight below 100 kDa

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, intensive care specialist

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 21, 2025
• Study Start: May 11, 2022
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 3 years after the publication of results
• Access Criteria: A proposal describing the planned analyses must be submitted, and a data sharing agreement must be signed. Documents should be submitted via email to sergej.godec@kclj.si.

Locations

SL (1)