Liver TransplantationNCT06890234
Tissue Microdialysis Monitoring of Liver Grafts
An observational study of Liver Transplantation and Liver Graft Dysfunction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Liver Graft Dysfunction, Tissue Metabolism
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 May 2022to 31 Dec 2025
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant candidates satisfying the inclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Applicability of Tissue Microdialysis for Early Assessment of Liver Graft Metabolism in Patients After Orthotopic Liver Transplantation
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.
- Keywords
- microdialysis, liver graft monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients (≥18 years old) who have undergone orthotopic liver transplantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of liver transplant surgery up to 5 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start11 May 2022
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergej Godec, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890234
- Sponsor's protocol ID
- 0120-505/2023/3
- Other IDs
- TP20230129, TP20240197
- Status last verified
- Jan 2025
- First submitted
- 16 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data, with only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applicability of Tissue Microdialysis for Early Assessment of Liver Graft Metabolism in Patients After Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT06890234
- Acronym / sponsor ID
- 0120-505/2023/3
- Keywords
- microdialysis, liver graft monitoring
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients (≥18 years old) who have undergone orthotopic liver transplantation | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant candidates satisfying the inclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The agreement between microdialysis-derived metabolite levels and conventional liver function tests
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. Raw data, with only IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Liver Graft Dysfunction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The agreement between microdialysis-derived metabolite levels and conventional liver function tests (time frame: From the end of liver transplant surgery up to 5 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.