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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: