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Enrolling by invitationNCT06890234Updated Mar 21, 2025

Tissue Microdialysis Monitoring of Liver Grafts

An observational study in Liver Transplantation, Liver Graft Dysfunction and Tissue Metabolism, sponsored by University Medical Centre Ljubljana. Enrolling by invitation at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by University Medical Centre Ljubljana · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Transplantation
  • Liver Graft Dysfunction
  • Tissue Metabolism

Keywords

  • microdialysis
  • liver graft monitoring
03

In context

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Liver transplant candidates satisfying the inclusion criteria.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Target follow-up
5 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adult patients (≥18 years old) who have undergone orthotopic liver transplantation
06

What researchers measure

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.

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

07

Study locations

1 site
  • University Medical Centre Ljubljana
    Ljubljana, 1000, Slovenia
08

References and documents

Individual participant data

Plan to share: Yes — Raw data, with only IPD used in the results publication.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06890234
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Sergej Godec (Medical Doctor, intensive care specialist, University Medical Centre Ljubljana) — Principal investigator
First posted
Mar 21, 2025
Start date
May 11, 2022
Primary completion
Aug 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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