Intraoperative Carotid Peak Systolic Velocity Variability... | NCT07442201

Studies
Intraoperative Carotid Peak Systolic Velocity Variability in Liver Transplant Patients

NCT07442201

Sponsor

Inonu University

Status

Completed

Last Update Posted

Mar 2, 2026Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Liver Transplant Disorder

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2023Actual

Primary Completion Date

Apr 29, 2024Actual

Completion Date

Jan 10, 2025Actual

First Submitted Date

May 21, 2025

First Submission Date that Met QC Criteria

Feb 24, 2026

First Posted Date

Mar 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Mar 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPSVv	carotid peak systolic velocity variability	During surgery: T0: Before vena cava inferior clamping T1: After vena cava inferior clamping

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients scheduled for elective liver transplantation

Exclusion Criteria:

fulminant hepatic failure requiring emergency transplantation, patients with carotid artery disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Liver transplant recipients received at İnönü University Liver Transplant Institute between 18.09.2023 and 29.04.2024

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
İnönü Üniversitesi Merkez Kampüsü (Elazığ Yolu 15.km) Battalgazi		Malatya	Turkey	44280	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26123610	Result	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.
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