Intraoperative Assessment of Microcirculatory Function Using Vascular Occlusion Test During Liver Transplantation

NCT07658794 | Not Yet Recruiting

• 1 other identifier: ΕΣ:87/18-3-2026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Early allograft dysfunction (EAD) remains one of the most important complications following orthotopic liver transplantation (OLT). Currently, there is no established intraoperative biomarker that reliably predicts graft dysfunction at an early stage. Near-infrared spectroscopy (NIRS) combined with the vascular occlusion test (VOT) is a non-invasive method for assessing tissue oxygenation and microcirculatory reserve. This prospective observational study aims to investigate whether VOT-derived parameters, including desaturation slope, recovery slope and post-ischemic hyperemic area under the curve (AUC-H), can predict EAD in liver transplant recipients. Measurements will be performed at four predefined intraoperative timepoints: after induction of anesthesia, during the anhepatic phase, during the neohepatic phase and at the end of surgery. The primary outcome is the occurrence of EAD according to Olthoff criteria.

Conditions

Liver Cirrhosis; Early Allograft Dysfunction

Keywords

Vascular Occlusion Test; Near-Infrared Spectroscopy; Early Allograft Dysfunction; Liver Transplantation; Microcirculation

Outcome Measures

Primary Outcomes (2)

• Incidence of Early Allograft Dysfunction Within 7 Days After Liver Transplantation

  Development of early allograft dysfunction after liver transplantation, defined according to established postoperative biochemical criteria, including elevated transaminases within the first 7 postoperative days, impaired coagulation, or hyperbilirubinemia.

  Within 7 days after liver transplantation

• Early Allograft Dysfunction

  Development of early allograft dysfunction after liver transplantation, defined according to established postoperative biochemical criteria, including elevated transaminases within the first 7 postoperative days, impaired coagulation, or hyperbilirubinemia.

  Within 7 days after liver transplantation

Study Arms (1)

Adult Liver Transplant Recipients Undergoing Intraoperative VOT/NIRS Monitoring

Adult patients undergoing orthotopic liver transplantation will be enrolled in this observational cohort. During surgery, they will undergo standardized Vascular Occlusion Tests using Near-Infrared Spectroscopy to assess peripheral tissue oxygen saturation and microcirculatory reactivity. Measurements will be performed at predefined intraoperative timepoints, including baseline, anhepatic, neohepatic and final phases. Reoxygenation slope, hyperemic area under the curve and related parameters will be analyzed for their association with early allograft dysfunction and postoperative outcomes.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients undergoing orthotopic liver transplantation at the participating center. Eligible patients will be enrolled before surgery and monitored intraoperatively using Near-Infrared Spectroscopy during standardized Vascular Occlusion Tests. The cohort will include liver transplant recipients managed according to standard institutional anesthetic, surgical and postoperative care protocols

You may qualify if:

• Adult patients aged 18 years or older
• Patients scheduled to undergo orthotopic liver transplantation
• Ability to obtain intraoperative Near-Infrared Spectroscopy measurements
• Written informed consent obtained before enrollment

You may not qualify if:

• Age younger than 18 years
• Refusal or inability to provide informed consent
• Emergency liver transplantation without sufficient time for enrollment
• Inability to perform the Vascular Occlusion Test or obtain reliable NIRS measurements
• Severe peripheral vascular disease or local upper-limb conditions interfering with monitoring

Sponsors & Collaborators

• Ippokrateio General Hospital of Thessaloniki: lead

Study Sites (1)

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, 54642, Greece

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dimitrios Zafeiriadis, MD

CONTACT

+306980422306; imdzaf@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dimitrios Zafeiriadis MD, Principal Investigator

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)