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Liver DiseaseNCT02306018

Evaluation of EV1000™/volumeView™ for Cardiac Output Monitoring in Liver Transplantation

An observational study of Liver Disease, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators are trying to evaluate the agreement of cardiac output measurements taken using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken using continuous pulmonary artery… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Liver Disease
What is being tested?
EV1000™/volumeView™
Type of treatment
Medical device
How many people
28 participants
Where
1 siteSouth Korea
Study dates
Oct 2014to Sep 2015
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients who are performed liver transplantation in Samsung medical center

Who may be able to join

  • subjects undergoing living donor liver transplantation during the study period subjects older than 20yrs who can give informed consent

Who cannot join

  • those who are confirmed moderate severe aortic regurgitation by echocardiography those with infection on cannulation site

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

Official title: Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation

The investigators are trying to evaluate the agreement of cardiac output measurements taken using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.

Read the detailed description

In cirrhotic patient undergoing liver transplantation, there are an altered patterm of circulation, which is characterized by increased cardiac output, decreased peripheral vascular resistance, and reduced ventricular response to physiological, pharmacological, and surgical stress. Large blood loss and clamping/declamping of the inferior vena cava and portal vein during liver transplantation surgery can affect intravascular volume status, which in turn can lead to hemodynamic instability. Therefore, reliable cardiac output monitoring is particularly useful in the cirrhotic patient undergoing liver transplant. Pulmonary artery thermodilution has been used as a standard method for cardiac output assessment for many years. Pulmonary artery catheter can cause rare but serious complications. And it has some limitations for continuously monitoring cardiac output during rapid hemodynamic changes.

Recently, several minimally invasive CO monitors have been developed. The pulse contour technique continuously estimates CO through mathematical analysis of the waveform of arterial pressure. However, previous studies evaluating the reliability of the pulse contour techniques indicated conflicting results in cirrhotic patients during liver transplantation. Most of studies were performed by analyzing from radial artery pressure waveform. Because of rapid changing of intravascular volume, using inotropics, the monitoring of femoral artery pressure has been recommended during liver transplantation.

A new pulse wave analysis system has developed and introduced into clinical practice that consists of a specific thermistor -tipped femoral arterial catheter ( the VolumeView™ catheter) and the EV1000™ monitoring platform ( Edward lifesciences, Irvine, CA, USA). To continuously assess CO based on the femoral arterial pressure curve signal and it uses transpulmonary thermodilution for calibration. We are trying to evaluate the agreement of cardiac output measurements taken using EV1000™ / VolumeView™ with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.

Conditions
Liver Disease
Being tested
EV1000™/volumeView™
Keywords
liver transplantation, cardiac output
Medical subject headings
Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EV1000™/volumeView™Device

Study groups in NCT02306018
Study groupRoleWhat they receive
EV1000™/volumeView™Not described
Receives: Device: EV1000™/volumeView™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiac output

    L/minute, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution

    Measured: intraoperative

Secondary outcomes (4)

  1. systemic vascular resistance

    dyne s/cm5,28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution

    Measured: intraoperative

  2. stroke volume variability

    %, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution

    Measured: during surgery every 10 minute, event time for example, anhepatic, liver in, reperfusion, using inotropics, changing ventilator setting

  3. stroke volume

    ml, 28 participants, EV1000 by femiral artery, Pulmonary artery thermodilution

    Measured: intraoperative

  4. ejection fraction

    %, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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
Case only
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02306018
Sponsor's protocol ID
2014-08-080-002
Status last verified
May 2016
First submitted
17 Oct 2014
Last updated
10 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Feltracco P, Biancofiore G, Ori C, Saner FH, Della Rocca G. Limits and pitfalls of haemodynamic monitoring systems in liver transplantation surgery. Minerva Anestesiol. 2012 Dec;78(12):1372-84. Epub 2012 Aug 3.

    PubMed 22858882

  • Uemura K, Kawada T, Inagaki M, Sugimachi M. A minimally invasive monitoring system of cardiac output using aortic flow velocity and peripheral arterial pressure profile. Anesth Analg. 2013 May;116(5):1006-1017. doi: 10.1213/ANE.0b013e31828a75bd. Epub 2013 Mar 14.

    PubMed 23492964

  • Biancofiore G, Critchley LA, Lee A, Bindi L, Bisa M, Esposito M, Meacci L, Mozzo R, DeSimone P, Urbani L, Filipponi F. Evaluation of an uncalibrated arterial pulse contour cardiac output monitoring system in cirrhotic patients undergoing liver surgery. Br J Anaesth. 2009 Jan;102(1):47-54. doi: 10.1093/bja/aen343.

    PubMed 19059920

  • Biancofiore G, Critchley LA, Lee A, Yang XX, Bindi LM, Esposito M, Bisa M, Meacci L, Mozzo R, Filipponi F. Evaluation of a new software version of the FloTrac/Vigileo (version 3.02) and a comparison with previous data in cirrhotic patients undergoing liver transplant surgery. Anesth Analg. 2011 Sep;113(3):515-22. doi: 10.1213/ANE.0b013e31822401b2. Epub 2011 Jun 16.

    PubMed 21680855

  • Tsai YF, Su BC, Lin CC, Liu FC, Lee WC, Yu HP. Cardiac output derived from arterial pressure waveform analysis: validation of the third-generation software in patients undergoing orthotopic liver transplantation. Transplant Proc. 2012 Mar;44(2):433-7. doi: 10.1016/j.transproceed.2011.12.045.

    PubMed 22410036

  • Galluccio ST, Chapman MJ, Finnis ME. Femoral-radial arterial pressure gradients in critically ill patients. Crit Care Resusc. 2009 Mar;11(1):34-8.

    PubMed 19281442

  • Arnal D, Garutti I, Perez-Pena J, Olmedilla L, Tzenkov IG. Radial to femoral arterial blood pressure differences during liver transplantation. Anaesthesia. 2005 Aug;60(8):766-71. doi: 10.1111/j.1365-2044.2005.04257.x.

    PubMed 16029225

  • Kim YK, Shin WJ, Song JG, Jun IG, Kim HY, Seong SH, Hwang GS. Comparison of stroke volume variations derived from radial and femoral arterial pressure waveforms during liver transplantation. Transplant Proc. 2009 Dec;41(10):4220-8. doi: 10.1016/j.transproceed.2009.09.050.

    PubMed 20005373

  • Sakka SG, Kozieras J, Thuemer O, van Hout N. Measurement of cardiac output: a comparison between transpulmonary thermodilution and uncalibrated pulse contour analysis. Br J Anaesth. 2007 Sep;99(3):337-42. doi: 10.1093/bja/aem177. Epub 2007 Jul 4.

    PubMed 17611251

  • Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1093/bja/aet116. Epub 2013 Apr 26.

    PubMed 23625132

  • Kiefer N, Hofer CK, Marx G, Geisen M, Giraud R, Siegenthaler N, Hoeft A, Bendjelid K, Rex S. Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters. Crit Care. 2012 May 30;16(3):R98. doi: 10.1186/cc11366.

    PubMed 22647561

  • Bendjelid K, Giraud R, Siegenthaler N, Michard F. Validation of a new transpulmonary thermodilution system to assess global end-diastolic volume and extravascular lung water. Crit Care. 2010;14(6):R209. doi: 10.1186/cc9332. Epub 2010 Nov 23.

    PubMed 21092252

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Disease, run by Samsung Medical Center at 1 site in South Korea.

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 1 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 10 May 2016. 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 South Korea. 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?

cardiac output (time frame: intraoperative). 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 NCT02306018, which also lists 12 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 10 May 2016.

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