- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Dimitrios Zafeiriadis, MD
- Telefonnummer: +30 +306980422306
- E-post: imdzaf@gmail.com
Studiesteder
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Thessaloniki
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Thessaloniki, Thessaloniki, Hellas, 54642
- Ippokrateio General Hospital of Thessaloniki
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Ta kontakt med:
- Dimitrios Zafeiriadis, MD
- Telefonnummer: +30 +306980422306
- E-post: imdzaf@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Incidence of Early Allograft Dysfunction Within 7 Days After Liver Transplantation
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ΕΣ:87/18-3-2026
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