Tissue Microdialysis Monitoring of Liver Grafts | NCT06890234

Studies
Tissue Microdialysis Monitoring of Liver Grafts

NCT06890234

Sponsor

University Medical Centre Ljubljana

Status

Enrolling by invitation

Last Update Posted

Mar 21, 2025Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Liver Transplantation
Liver Graft Dysfunction
Tissue Metabolism

Interventions

Not provided

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TP20230129	Other Grant/Funding Number	UMC Ljubljana
TP20240197	Other Grant/Funding Number	UMC Ljubljana

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2022Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 16, 2025

First Submission Date that Met QC Criteria

Mar 16, 2025

First Posted Date

Mar 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2025

Last Update Posted Date

Mar 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sergej Godec, Medical Doctor, intensive care specialist, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Label	Type	Description	Intervention Names
Adult patients (≥18 years old) who have undergone orthotopic liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	From the end of liver transplant surgery up to 5 days post-transplant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Liver transplant candidates satisfying the inclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Centre Ljubljana		Ljubljana	Slovenia	1000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Raw data, with only IPD used in the results publication.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Beginning 6 months and ending 3 years after the publication of results

Access Criteria

A proposal describing the planned analyses must be submitted, and a data sharing agreement must be signed. Documents should be submitted via email to sergej.godec@kclj.si.

URL

Not provided