View of Cerebral Perfusion in Liver Transplantation

NCT07442214 | Active Not Recruiting FDA Device

• 1 other identifier: InonuNIRS
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-stage Liver Disease (ESLD); Liver Transplantation; Cerebral Perfusion; Intraoperative Monitoring

Keywords

End-Stage Liver Disease; Liver Transplantation; Cerebral Perfusion; Intraoperative Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• PPV

  During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase

• CI

  During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase

Study Arms (1)

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)

Interventions

Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS) DEVICE

Non-invasive intraoperative monitoring of cerebral perfusion using NIRS and carotid Doppler.

Adult Patients Undergoing Liver Transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Eligibility is based on biological sex. Both male and female adult patients undergoing liver transplantation are eligible for inclusion. No restrictions are applied based on gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Turgut Ozal Medical Center.

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 25735719 BACKGROUND

• 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.

  PMID: 14501855 BACKGROUND

• 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.

  PMID: 31094772 BACKGROUND

• 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.

  PMID: 28969313 BACKGROUND

• 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.

  PMID: 26123610 BACKGROUND

• 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.

  PMID: 37602090 BACKGROUND

• 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.

  PMID: 34801217 BACKGROUND

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Dr.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: March 2, 2026
• Study Start: February 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 15, 2026
• Last Updated: March 2, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)