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

NCT ID: NCT04825015

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-12-15

Brief Summary

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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

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Conditions

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Cardiac Output, Low Liver Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OLTx

Liver insufficiency patients undergoing transplantation surgery

VEnaRt Cardiac Output

Intervention Type DEVICE

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

Interventions

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VEnaRt Cardiac Output

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

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Luigi Vetrugno

Clinical Professor in Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 18581507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26052376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20634793 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2868172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18946716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12578081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20736431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29725794 (View on PubMed)

Other Identifiers

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CEUR-2020-OS-299

Identifier Type: -

Identifier Source: org_study_id

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