View of Cerebral Perfusion in Liver Transplantation (NIRS/Doppler)

Comparison of Carotid Doppler Ultrasonography With Cerebral Oximetry in Assessing Cerebral Perfusion in Liver Transplantation Surgery

Investigator's aim in this study is to compare the more accessible and low-cost Carotid Doppler USG measurements, which are relatively more difficult to access, costly, and have technical disadvantages, and to demonstrate their superiority over each other in the evaluation of cerebral perfusion in liver transplantation surgeries, without any invasive intervention to the patient.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Transplantation; Cerebral Perfusion; Intraoperative Monitoring; End-stage Liver Disease (ESLD)
• Intervention / Treatment: Device: Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS)

Detailed Description

Liver transplant surgeries cause intraoperative problems that are difficult to manage from hemodynamic, respiratory, neurological, hematological, and metabolic perspectives due to the nature of liver failure, which affects many organs and systems. Particularly during the anhepatic period, when the healthy graft is integrated into the recipient's vascular system, clamping of the inferior vena cava, one of the two main veins of the hepatic veins, is often required for its connection. This means that a sudden interruption occurs in the blood volume returning to the heart from the lower part of the body, which constitutes half of the total cardiac output.

Cerebral perfusion is also affected during the anhepatic period, and previous studies have observed impaired cerebral perfusion using cerebral oximetry. However, not every clinic has a cerebral oximetry device, and there are factors that limit its use. Some of these factors include high cost, hyperbilirubinemia, variables that disrupt regional blood flow, diabetes, hypertension, and low hemoglobin.

Ultrasound devices are more commonly available in large clinical centers that perform liver transplant surgeries, even for other purposes. It is possible to evaluate the blood flow to the brain using carotid Doppler ultrasonography. The aim of this study is to measure patients' carotid peak systolic and end-diastolic flow and carotid peak systolic flow variability using carotid Doppler ultrasonography and to compare these measurements with cerebral oximetry measurements.

Translated with DeepL.com (free version)

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Battalgazi
    • Malatya, Battalgazi, Turkey (Türkiye), 44280
      • Inonu University Turgut Ozal Medical Center.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18-65 years who underwent elective liver transplantation at Inonu University Turgut Ozal Medical Center. All participants had end-stage liver disease and were monitored intraoperatively for cerebral perfusion using carotid Doppler ultrasonography and near-infrared spectroscopy (NIRS). The study was conducted as a single-center, prospective observational study.

Description

Inclusion Criteria:

• Adult patients aged 18-65 years scheduled for elective liver transplantation
• Written informed consent obtained prior to participation

Exclusion Criteria:

• Fulminant hepatic failure
• Hepatic encephalopathy
• Hepatorenal or hepatopulmonary syndrome
• Pre-existing cerebrovascular disease or carotid stenosis
• Severe cardiopulmonary comorbidity
• Refusal to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult Patients Undergoing Liver Transplantation; This cohort includes adult patients undergoing elective liver transplantation who were monitored for cerebral perfusion using near-infrared spectroscopy (NIRS) and carotid Doppler ultrasonography.	Device: Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS); Non-invasive intraoperative monitoring of cerebral perfusion using NIRS and carotid Doppler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSv	peak systolic velocity (PS) cm/sec)	During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
rSO₂	regional cerebral oxygen saturation (%)	During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPV	pulse pressure variation (%)	During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
CI	cardiac index (L/min/m2)	During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase

Collaborators and Investigators

• Sponsor: Inonu University

Publications and helpful links

General Publications

• Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26.
• Rogers CA, Stoica S, Ellis L, Stokes EA, Wordsworth S, Dabner L, Clayton G, Downes R, Nicholson E, Bennett S, Angelini GD, Reeves BC, Murphy GJ. Randomized trial of near-infrared spectroscopy for personalized optimization of cerebral tissue oxygenation during cardiac surgery. Br J Anaesth. 2017 Sep 1;119(3):384-393. doi: 10.1093/bja/aex182.
• Bevan PJ. Should Cerebral Near-infrared Spectroscopy be Standard of Care in Adult Cardiac Surgery? Heart Lung Circ. 2015 Jun;24(6):544-50. doi: 10.1016/j.hlc.2015.01.011. Epub 2015 Feb 7.
• Ohdan H, Mizunuma K, Tashiro H, Tokita D, Hara H, Onoe T, Ishiyama K, Shibata S, Mitsuta H, Ochi M, Nakahara H, Itamoto T, Asahara T. Intraoperative near-infrared spectroscopy for evaluating hepatic venous outflow in living-donor right lobe liver. Transplantation. 2003 Sep 15;76(5):791-7. doi: 10.1097/01.TP.0000074603.36553.BD.
• Holmgaard F, Vedel AG, Lange T, Nilsson JC, Ravn HB. Impact of 2 Distinct Levels of Mean Arterial Pressure on Near-Infrared Spectroscopy During Cardiac Surgery: Secondary Outcome From a Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1081-1088. doi: 10.1213/ANE.0000000000003418.
• Roy A, Pachisia AV, Govil D, Kn J, Patel S, Harne R, Pal D, Reddy DM, Tyagi P, Pattajoshi S. Fluid Responsiveness in Critically Ill Patients Using Carotid Peak Systolic Velocity Variability: A New Frontier. Cureus. 2023 Jul 18;15(7):e42083. doi: 10.7759/cureus.42083. eCollection 2023 Jul.
• Ramsingh D, Staab J, Flynn B. Application of perioperative hemodynamics today and potentials for tomorrow. Best Pract Res Clin Anaesthesiol. 2021 Dec;35(4):551-564. doi: 10.1016/j.bpa.2021.01.005. Epub 2021 Feb 4.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 15, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Liver Transplantation; Intraoperative Monitoring; Cerebral Perfusion; End-Stage Liver Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Chemistry Techniques, Analytical; Spectrum Analysis; Spectroscopy, Near-Infrared
• Other Study ID Numbers: InonuNIRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to ethical restrictions and institutional data protection policies. Only aggregated anonymized results will be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes