Tissue Microdialysis Monitoring of Liver Grafts

NCT ID: NCT06890234

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-11

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Liver Transplantation Liver Graft Dysfunction Tissue Metabolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Sergej Godec

Medical Doctor, intensive care specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre Ljubljana

Ljubljana, Slovenia, Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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TP20230129

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TP20240197

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0120-505/2023/3

Identifier Type: -

Identifier Source: org_study_id

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