Cardiac Output, LowVERONCT04825015
Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter (VERO Study)
An observational study of Cardiac Output, Low and Liver Transplant; Complications, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Output, Low, Liver Transplant; Complications
- What is being tested?
- VEnaRt Cardiac Output
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 15 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients undergoing liver transplant at our institution
Who may be able to join
- liver transplantation patients
Who cannot join
- age < 18 years old
- combined liver-kidney transplant
- liver transplant for acute insufficiency
- no consent of the patient
Trial locations and contacts
1 site in 1 country.
Italy1 site
Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Udine, 33100
About this study
Official title: 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.
- Being tested
- VEnaRt Cardiac Output
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEnaRt Cardiac OutputDevice
Every patient is monitored during liver transplantation with VEnaRt Cardiac Output versus Swan-Ganz Catheter
| Study group | Role | What they receive |
|---|---|---|
| OLTx | Liver insufficiency patients undergoing transplantation surgery Receives: Device: VEnaRt Cardiac Output |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During surgery
Secondary outcomes (4)
Correlation
Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical correlation of cardiac output and cardiac index measures
Measured: During surgery
Concordance
Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical concordance of cardiac output and cardiac index measures
Measured: During surgery
Time of device positioning
Evaluate the time necessary to position the VenArt Cardiac Output and Swan-Ganz catheter
Measured: During surgery
Device positioning complications
Evaluate the complication during the VenArt Cardiac Output and Swan-Ganz catheter positioning.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825015
- Sponsor's protocol ID
- CEUR-2020-OS-299
- Acronym
- VERO
- Status last verified
- Aug 2023
- First submitted
- 26 Mar 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18581507Rudnick 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.
PubMed 26052376Cecconi 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.
PubMed 20634793Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Weinbroum 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.
PubMed 18946716Critchley 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.
PubMed 12578081Critchley 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.
PubMed 20736431Vetrugno 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.
PubMed 29725794
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter VERO Study
- ClinicalTrials.gov ID
- NCT04825015
- Acronym / sponsor ID
- VERO / CEUR-2020-OS-299
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLTx | – | Device: VEnaRt Cardiac OutputLiver insufficiency patients undergoing transplantation surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients undergoing liver transplant at our institution
Key inclusion criteria (1 listed)
- liver transplantation patients
Key exclusion criteria (4 listed)
- age < 18 years old
- combined liver-kidney transplant
- liver transplant for acute insufficiency
- no consent of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEnaRt Cardiac OutputEvery patient is monitored during liver transplantation with VEnaRt Cardiac Output versus Swan-Ganz Catheter | Device | OLTx |
Primary outcome
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
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
4 secondary outcomes
Correlation
Time frame: During surgery
Concordance
Time frame: During surgery
Time of device positioning
Time frame: During surgery
Device positioning complications
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Background: PubMed 18581507De 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.
- Background: PubMed 26052376Rudnick 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.
- Background: PubMed 20634793Cecconi 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.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 18946716Weinbroum 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.
- Background: PubMed 12578081Critchley 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.
- Background: PubMed 20736431Critchley 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.
- Background: PubMed 29725794Vetrugno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low and Liver Transplant; Complications, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures (time frame: During surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825015, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.