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

The Predictive Value of the Vascular Occlusion Test During Orthotopic Liver Transplantation for the Development of Early Allograft Dysfunction

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07658794
Enrollment
50
Registered
2026-06-22
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Allograft Dysfunction, Liver Cirrhosis

Keywords

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

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.

Detailed description

Orthotopic liver transplantation (OLT) is the treatment of choice for patients with end-stage liver disease and acute liver failure. Despite advances in surgical technique and perioperative management, early allograft dysfunction (EAD) remains a common postoperative complication associated with increased morbidity, prolonged intensive care unit stay and reduced graft survival. Increasing evidence suggests that microcirculatory dysfunction may play a pivotal role in the pathophysiology of ischemia-reperfusion injury and graft dysfunction after OLT. In contrast to conventional macrocirculatory monitoring, microcirculatory assessment provides direct information regarding tissue oxygenation, endothelial function and the adequacy of oxygen delivery at the cellular level. Near-infrared spectroscopy (NIRS) combined with the vascular occlusion test (VOT) is a non-invasive and well-established technique for evaluating microvascular reactivity. During VOT, transient arterial occlusion is induced using a pneumatic cuff, while tissue oxygen saturation (StO₂) is continuously recorded. Parameters derived from the test include the desaturation slope (downslope), the recovery slope (upslope) and the area under the post-ischemic hyperemic curve (AUC-H), reflecting tissue oxygen consumption, endothelial function and microvascular reserve, respectively. The present study is a prospective, single-center observational cohort study aiming to investigate the prognostic value of VOT-derived parameters in liver transplant recipients. VOT measurements will be performed at four predefined intraoperative timepoints: following induction of anesthesia (baseline), during the anhepatic phase, during the neohepatic phase after graft reperfusion, and at the end of surgery. The primary endpoint is the occurrence of early allograft dysfunction according to the Olthoff criteria. Secondary outcomes include intensive care unit length of stay, hospital length of stay, duration of mechanical ventilation and established liver transplant outcome scores including L-GrAFT, EASE and EASIX. In addition, exploratory analyses will investigate the relationship between VOT-derived parameters normalized to oxygen delivery (DO₂ and DO₂I) and postoperative outcomes, aiming to determine whether microcirculatory reserve adjusted for systemic oxygen transport provides superior prognostic information.

Interventions

None listed

Sponsors

Ippokrateio General Hospital of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Early Allograft Dysfunction Within 7 Days After Liver TransplantationWithin 7 days after liver transplantationDevelopment 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.
Early Allograft DysfunctionWithin 7 days after liver transplantationDevelopment 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.

Countries

Greece

Contacts

CONTACTDimitrios Zafeiriadis, MD
imdzaf@gmail.com+306980422306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026