- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442201
Intraoperative Carotid Peak Systolic Velocity Variability in Liver Transplant Patients (CPSV)
Evaluation of Intraoperative Carotid Peak Systolic Velocity Variability in Liver Transplant Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Turkey
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Malatya, Turkey, Turkey (Türkiye), 44280
- İnönü Üniversitesi Merkez Kampüsü (Elazığ Yolu 15.km) Battalgazi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients scheduled for elective liver transplantation
Exclusion Criteria:
- fulminant hepatic failure requiring emergency transplantation, patients with carotid artery disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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CPSVv
Time Frame: During surgery: T0: Before vena cava inferior clamping T1: After vena cava inferior clamping
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carotid peak systolic velocity variability
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During surgery: T0: Before vena cava inferior clamping T1: After vena cava inferior clamping
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Collaborators and Investigators
Sponsor
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.
- 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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Inonu CPSV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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