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

Liver Transplant; Complications Clinical Trial

— VERO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825015
• Other study ID #: CEUR-2020-OS-299
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: August 2023
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Liver Transplant; Complications

Intervention

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

Locations

Country	Name	City	State
Italy	Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. — View Citation

Cecconi M, Dawson D, Casaretti R, Grounds RM, Rhodes A. A prospective study of the accuracy and precision of continuous cardiac output monitoring devices as compared to intermittent thermodilution. Minerva Anestesiol. 2010 Dec;76(12):1010-7. Epub 2010 Jul 16. — View Citation

Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput. 1999 Feb;15(2):85-91. doi: 10.1023/a:1009982611386. — View Citation

Critchley LA, Lee A, Ho AM. A critical review of the ability of continuous cardiac output monitors to measure trends in cardiac output. Anesth Analg. 2010 Nov;111(5):1180-92. doi: 10.1213/ANE.0b013e3181f08a5b. Epub 2010 Aug 24. — View Citation

De Wolf AM. Pulmonary artery catheter: rest in peace? Not just quite yet.. Liver Transpl. 2008 Jul;14(7):917-8. doi: 10.1002/lt.21543. No abstract available. — View Citation

Rudnick MR, Marchi LD, Plotkin JS. Hemodynamic monitoring during liver transplantation: A state of the art review. World J Hepatol. 2015 Jun 8;7(10):1302-11. doi: 10.4254/wjh.v7.i10.1302. — View Citation

Vetrugno L, Bignami E, Barbariol F, Langiano N, De Lorenzo F, Matellon C, Menegoz G, Della Rocca G. Cardiac output measurement in liver transplantation patients using pulmonary and transpulmonary thermodilution: a comparative study. J Clin Monit Comput. 2019 Apr;33(2):223-231. doi: 10.1007/s10877-018-0149-9. Epub 2018 May 3. — View Citation

Weinbroum AA, Biderman P, Soffer D, Klausner JM, Szold O. Reliability of cardiac output calculation by the fick principle and central venous oxygen saturation in emergency conditions. J Clin Monit Comput. 2008 Oct;22(5):361-6. doi: 10.1007/s10877-008-9143-y. Epub 2008 Oct 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures	Evaluate the precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output versus the pulmonary catheter in patients undergoing liver transplantation	During surgery
Primary	Accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures	Evaluate the accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output versus the pulmonary catheter in patients undergoing liver transplantation	During surgery
Secondary	Correlation	Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical correlation of cardiac output and cardiac index measures	During surgery
Secondary	Concordance	Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical concordance of cardiac output and cardiac index measures	During surgery
Secondary	Time of device positioning	Evaluate the time necessary to position the VenArt Cardiac Output and Swan-Ganz catheter	During surgery
Secondary	Device positioning complications	Evaluate the complication during the VenArt Cardiac Output and Swan-Ganz catheter positioning.	During surgery