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OpenTrials
Completed

NCT Number: NCT04825015

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VEnaRt Cardiac Output

Device

Every patient is monitored during liver transplantation with VEnaRt Cardiac Output versus Swan-Ganz Catheter

Primary outcomes

  1. Precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures

    Time frame: 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

  2. Accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures

    Time frame: 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 outcomes

  1. Correlation

    Time frame: During surgery

    Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical correlation of cardiac output and cardiac index measures

  2. Concordance

    Time frame: During surgery

    Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical concordance of cardiac output and cardiac index measures

  3. Time of device positioning

    Time frame: During surgery

    Evaluate the time necessary to position the VenArt Cardiac Output and Swan-Ganz catheter

  4. Device positioning complications

    Time frame: During surgery

    Evaluate the complication during the VenArt Cardiac Output and Swan-Ganz catheter positioning.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

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

Acronym: VERO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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