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- Ensayo clínico NCT07658794
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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dimitrios Zafeiriadis, MD
- Número de teléfono: +30 +306980422306
- Correo electrónico: imdzaf@gmail.com
Ubicaciones de estudio
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Thessaloniki
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Thessaloniki, Thessaloniki, Grecia, 54642
- Ippokrateio General Hospital of Thessaloniki
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Contacto:
- Dimitrios Zafeiriadis, MD
- Número de teléfono: +30 +306980422306
- Correo electrónico: imdzaf@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Early Allograft Dysfunction Within 7 Days After Liver Transplantation
Periodo de tiempo: Within 7 days after liver transplantation
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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.
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Within 7 days after liver transplantation
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Early Allograft Dysfunction
Periodo de tiempo: Within 7 days after liver transplantation
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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.
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Within 7 days after liver transplantation
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
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Otros números de identificación del estudio
- ΕΣ:87/18-3-2026
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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