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Enrolling by Invitation

NCT Number: NCT06890234

Tissue Microdialysis Monitoring of Liver Grafts

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.

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Key information

Conditions

Liver Transplantation Liver Graft Dysfunction Tissue Metabolism

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ljubljana

Ljubljana, Slovenia, 1000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Clinical Applicability of Tissue Microdialysis for Early Assessment of Liver Graft Metabolism in Patients After Orthotopic Liver Transplantation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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