End-stage Liver Disease (ESLD)NIRS/DopplerNCT07442214
View of Cerebral Perfusion in Liver Transplantation
An observational study of End-stage Liver Disease (ESLD) and Liver Transplantation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- End-stage Liver Disease (ESLD), Liver Transplantation, Cerebral Perfusion
- What is being tested?
- Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 15 Apr 2026
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged 18-65 years scheduled for elective liver transplantation
- Written informed consent obtained prior to participation
Who cannot join
- Fulminant hepatic failure
- Hepatic encephalopathy
- Hepatorenal or hepatopulmonary syndrome
- Pre-existing cerebrovascular disease or carotid stenosis
- Severe cardiopulmonary comorbidity
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center.
Malatya, Battalgazi, 44280
About this study
Official title: 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.
Read the 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)
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplantation, Cerebral Perfusion, Intraoperative Monitoring
- Being tested
- Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS)
- Keywords
- End-Stage Liver Disease, Liver Transplantation, Cerebral Perfusion, Intraoperative Monitoring
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS)Device
Non-invasive intraoperative monitoring of cerebral perfusion using NIRS and carotid Doppler.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSv
peak systolic velocity (PS) cm/sec)
Measured: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
rSO₂
regional cerebral oxygen saturation (%)
Measured: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
Secondary outcomes (2)
PPV
pulse pressure variation (%)
Measured: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
CI
cardiac index (L/min/m2)
Measured: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Feb 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for End-stage Liver Disease (ESLD)Studies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ziya ÇOLAK, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442214
- Sponsor's protocol ID
- InonuNIRS
- Acronym
- NIRS/Doppler
- Status last verified
- Apr 2025
- First submitted
- 25 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25735719Ohdan 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.
PubMed 14501855Holmgaard 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.
PubMed 31094772Rogers 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.
PubMed 28969313Ibarra-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.
PubMed 26123610Roy 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.
PubMed 37602090Ramsingh 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.
PubMed 34801217
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Carotid Doppler Ultrasonography With Cerebral Oximetry in Assessing Cerebral Perfusion in Liver Transplantation Surgery
- ClinicalTrials.gov ID
- NCT07442214
- Acronym / sponsor ID
- NIRS/Doppler / InonuNIRS
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplantation, Cerebral Perfusion, Intraoperative Monitoring
- Keywords
- End-Stage Liver Disease, Liver Transplantation, Cerebral Perfusion, Intraoperative Monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients Undergoing Liver Transplantation | – | Device: Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS)This cohort includes adult patients undergoing elective liver transplantation who were monitored for cerebral perfusion using near-infrared spectroscopy (NIRS) and carotid Doppler ultrasonography. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients aged 18-65 years scheduled for elective liver transplantation
- Written informed consent obtained prior to participation
Key exclusion criteria (6 listed)
- Fulminant hepatic failure
- Hepatic encephalopathy
- Hepatorenal or hepatopulmonary syndrome
- Pre-existing cerebrovascular disease or carotid stenosis
- Severe cardiopulmonary comorbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Doppler Ultrasonography and Near-Infrared Spectroscopy (NIRS)Non-invasive intraoperative monitoring of cerebral perfusion using NIRS and carotid Doppler. | Device | Adult Patients Undergoing Liver Transplantation |
Primary outcome
PSv
Time frame: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
peak systolic velocity (PS) cm/sec)
rSO₂
Time frame: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
regional cerebral oxygen saturation (%)
2 secondary outcomes
PPV
Time frame: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
CI
Time frame: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 25735719Bevan 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.
- Background: PubMed 14501855Ohdan 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.
- Background: PubMed 31094772Holmgaard 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.
- Background: PubMed 28969313Rogers 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.
- Background: PubMed 26123610Ibarra-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.
- Background: PubMed 37602090Roy 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.
- Background: PubMed 34801217Ramsingh 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Liver Disease (ESLD) and Liver Transplantation, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSv (time frame: During surgery: T0: Preanhepatic phase T1: Anhepatic phase T2: Neohepatic phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07442214, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.