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

27. juni 2026 oppdatert av: Dimitrios Zafeiriadis, Ippokrateio General Hospital of Thessaloniki

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

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

Observasjonsmessig

Registrering (Antatt)

50

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Dimitrios Zafeiriadis, MD
  • Telefonnummer: +30 +306980422306
  • E-post: imdzaf@gmail.com

Studiesteder

    • Thessaloniki
      • Thessaloniki, Thessaloniki, Hellas, 54642
        • Ippokrateio General Hospital of Thessaloniki
        • Ta kontakt med:
          • Dimitrios Zafeiriadis, MD
          • Telefonnummer: +30 +306980422306
          • E-post: imdzaf@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Early Allograft Dysfunction Within 7 Days After Liver Transplantation
Tidsramme: 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.
Within 7 days after liver transplantation
Early Allograft Dysfunction
Tidsramme: 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.
Within 7 days after liver transplantation

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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