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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIppokrateio General Hospital of Thessaloniki

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Adult Liver Transplant Recipients Undergoing Intraoperative VOT/NIRS Monitoring

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 7 days after liver transplantation
2

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.

Time frame
Within 7 days after liver transplantation

Secondary outcomes

Other outcomes

Sponsors and contacts

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