Liver Transplant DisorderCPSVNCT07442201
Intraoperative Carotid Peak Systolic Velocity Variability in Liver Transplant Patients
An observational study of Liver Transplant Disorder, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate carotid peak systolic velocity variability using intraoperative ultrasound and to determine whether this method is useful in the assessment of hemodynamic status and intravascular volume in liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant Disorder
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2023to 10 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Liver transplant recipients received at İnönü University Liver Transplant Institute between 18.09.2023 and 29.04.2024
Who may be able to join
- Adult patients scheduled for elective liver transplantation
Who cannot join
- fulminant hepatic failure requiring emergency transplantation, patients with carotid artery disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İnönü Üniversitesi Merkez Kampüsü (Elazığ Yolu 15.km) Battalgazi
Malatya, Turkey, 44280
About this study
Official title: Evaluation of Intraoperative Carotid Peak Systolic Velocity Variability in Liver Transplant Patients
The aim of this study was to evaluate carotid peak systolic velocity variability using intraoperative ultrasound and to determine whether this method is useful in the assessment of hemodynamic status and intravascular volume in liver transplantation. Previously, a similar study was performed in liver transplant intensive care unit, but no study was performed to evaluate intraperative fluid status with carotid ultrasonography.
Read the detailed description
Aim: The aim of this study was to evaluate carotid peak systolic velocity variability using intraoperative ultrasound and to determine whether this method is useful in the assessment of hemodynamic status and intravascular volume in liver transplantation. Previously, a similar study was performed in liver transplant intensive care unit, but no study was performed to evaluate intraperative fluid status with carotid ultrasonography.
Material and Method: Our prospective, single-center study was conducted at the Inonu University Faculty of Medicine, Turgut Ozal Medical Center Liver Transplant Institute, between Semtember 18, 2023, and April 29, 2024. After excluding patients with fulminant hepatic failure requiring emergency transplantation and those outside the age range of 18-65 years, 42 patients out of a total of 89 liver transplant recipients were included. Masimo non-invasive probe was inserted for pleth variable index (PVI), perfusion index (PI), oxygen reserve index (ORI), SpHb measurement and input values were recorded. After invasive arterial monitoring, which is routinely performed in transplant patients, cardiac output, stroke volume, stroke volume variation, dPmax were monitored by pulse contour analysis method and values were recorded. At the beginning of the dissection phase, carotid ultrasound was performed and values were recorded (T0). After the portal vein and v. cava inf. were clamped (anhepatic period), carotid ultrasound was performed and values were recorded (T1). Hemodynamic, respiratory, routine laboratory data and hourly urine output were recorded throughout the operation.
- Conditions
- Liver Transplant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipients | After excluding patients with fulminant hepatic failure requiring emergency transplantation and those outside the age range of 18-65 years, 42 patients out of a total of 89 liver transplant recipients were included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPSVv
carotid peak systolic velocity variability
Measured: During surgery: T0: Before vena cava inferior clamping T1: After vena cava inferior clamping
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 start18 Sep 2023
- Primary completion29 Apr 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 1 Day
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
- NCT07442201
- Sponsor's protocol ID
- Inonu CPSV
- Acronym
- CPSV
- Status last verified
- Sep 2023
- First submitted
- 21 May 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have the necessary infrastructure
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.
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
- Evaluation of Intraoperative Carotid Peak Systolic Velocity Variability in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT07442201
- Acronym / sponsor ID
- CPSV / Inonu CPSV
- Conditions
- Liver Transplant Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- 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.
The aim of this study was to evaluate carotid peak systolic velocity variability using intraoperative ultrasound and to determine whether this method is useful in the assessment of hemodynamic status and intravascular volume in liver transplantation. Previously, a similar study was performed in liver transplant intensive care unit, but no study was performed to evaluate intraperative fluid status with carotid ultrasonography.
Detailed description
Aim: The aim of this study was to evaluate carotid peak systolic velocity variability using intraoperative ultrasound and to determine whether this method is useful in the assessment of hemodynamic status and intravascular volume in liver transplantation. Previously, a similar study was performed in liver transplant intensive care unit, but no study was performed to evaluate intraperative fluid status with carotid ultrasonography.
Material and Method: Our prospective, single-center study was conducted at the Inonu University Faculty of Medicine, Turgut Ozal Medical Center Liver Transplant Institute, between Semtember 18, 2023, and April 29, 2024. After excluding patients with fulminant hepatic failure requiring emergency transplantation and those outside the age range of 18-65 years, 42 patients out of a total of 89 liver transplant recipients were included. Masimo non-invasive probe was inserted for pleth variable index (PVI), perfusion index (PI), oxygen reserve index (ORI), SpHb measurement and input values were recorded. After invasive arterial monitoring, which is routinely performed in transplant patients, cardiac output, stroke volume, stroke volume variation, dPmax were monitored by pulse contour analysis method and values were recorded. At the beginning of the dissection phase, carotid ultrasound was performed and values were recorded (T0). After the portal vein and v. cava inf. were clamped (anhepatic period), carotid ultrasound was performed and values were recorded (T1). Hemodynamic, respiratory, routine laboratory data and hourly urine output were recorded throughout the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipients | – | –After excluding patients with fulminant hepatic failure requiring emergency transplantation and those outside the age range of 18-65 years, 42 patients out of a total of 89 liver transplant recipients were included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant recipients received at İnönü University Liver Transplant Institute between 18.09.2023 and 29.04.2024
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective liver transplantation
Key exclusion criteria (1 listed)
- fulminant hepatic failure requiring emergency transplantation, patients with carotid artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CPSVv
Time frame: During surgery: T0: Before vena cava inferior clamping T1: After vena cava inferior clamping
carotid peak systolic velocity variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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. We do not have the necessary infrastructure
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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 Liver Transplant Disorder, 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 1 inclusion and 1 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CPSVv (time frame: During surgery: T0: Before vena cava inferior clamping T1: After vena cava inferior clamping). 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 NCT07442201, which also lists 3 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.