Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter (VERO Study)

Completed

• Conditions: Liver Transplant; Complications; Cardiac Output, Low
• Interventions: Device: VEnaRt Cardiac Output

• Registration Number: NCT04825015
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Brief Summary

The Swan-Ganz catheter is the gold standard to measure cardiac output during liver transplantation surgery. This is an invasive hemodynamic monitoring system.

The VenArt Cardiac Output (Mespere LifeSciences, Waterloo, Canada) is a new, innovative and non-invasive device that permits hemodynamic monitoring.

With a software based on Fick's principle it is able to calculate cardiac output, cardiac index and continuous cardiac output.

The hypothesis of this study is to investigate the precision and accuracy of this method versus the standard of care during liver transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-29
• Study Start: 2021-04-01
• Study First Posted: 2021-04-01
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• liver transplantation patients

Exclusion Criteria

• age < 18 years old
• combined liver-kidney transplant
• liver transplant for acute insufficiency
• no consent of the patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OLTx	VEnaRt Cardiac Output	Liver insufficiency patients undergoing transplantation surgery

Primary Outcome Measures

Name	Time	Method
Precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures	During surgery	Evaluate the precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output versus the pulmonary catheter in patients undergoing liver transplantation
Accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures	During surgery	Evaluate the accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output versus the pulmonary catheter in patients undergoing liver transplantation

Secondary Outcome Measures

Name	Time	Method
Device positioning complications	During surgery	Evaluate the complication during the VenArt Cardiac Output and Swan-Ganz catheter positioning.
Correlation	During surgery	Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical correlation of cardiac output and cardiac index measures
Time of device positioning	During surgery	Evaluate the time necessary to position the VenArt Cardiac Output and Swan-Ganz catheter
Concordance	During surgery	Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical concordance of cardiac output and cardiac index measures

Trial Locations

Locations (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD; 🇮🇹 Udine, Italy