Tissue Microdialysis Monitoring of Liver Grafts

University Medical Centre Ljubljana

Status: Invitation-only

Conditions: Liver Transplantation; Tissue Metabolism; Liver Graft Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT06890234

0120-505/2023/3

TP20230129 (Other Grant/Funding Number)

TP20240197 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 1 patient group

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