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

NCT04825015 | Completed FDA Device

• 1 other identifier: CEUR-2020-OS-299
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output, Low; Liver Transplant; Complications

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Correlation

  During surgery

• Concordance

  During surgery

• Time of device positioning

  During surgery

• Device positioning complications

  During surgery

Study Arms (1)

OLTx

Liver insufficiency patients undergoing transplantation surgery

Device: VEnaRt Cardiac Output

Interventions

VEnaRt Cardiac Output DEVICE

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

OLTx

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients undergoing liver transplant at our institution

You may qualify if:

• liver transplantation patients

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Related Publications (8)

• 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.

  PMID: 18581507 BACKGROUND

• 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.

  PMID: 26052376 BACKGROUND

• 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.

  PMID: 20634793 BACKGROUND

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

  PMID: 2868172 BACKGROUND

• 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.

  PMID: 18946716 BACKGROUND

• 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.

  PMID: 12578081 BACKGROUND

• 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.

  PMID: 20736431 BACKGROUND

• 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.

  PMID: 29725794 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)