NCT02306018

Brief 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 thermodilution cardiac output monitoring during orthotopic liver transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

11 months

First QC Date

October 17, 2014

Last Update Submit

May 7, 2016

Conditions

Liver Disease

Keywords

liver transplantationcardiac output

Outcome Measures

Primary Outcomes (1)

  • cardiac output

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

    intraoperative

Secondary Outcomes (4)

  • systemic vascular resistance

    intraoperative

  • stroke volume variability

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

  • stroke volume

    intraoperative

  • ejection fraction

    intraoperative

Study Arms (1)

EV1000™/volumeView™

Device: EV1000™/volumeView™

Interventions

EV1000™/volumeView™DEVICE
EV1000™/volumeView™

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who are performed liver transplantation in Samsung medical center

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (12)

  • 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.

    PMID: 22858882RESULT

  • 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.

    PMID: 23492964RESULT

  • 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.

    PMID: 19059920RESULT

  • 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.

    PMID: 21680855RESULT

  • 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.

    PMID: 22410036RESULT

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

    PMID: 19281442RESULT

  • 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.

    PMID: 16029225RESULT

  • 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.

    PMID: 20005373RESULT

  • 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.

    PMID: 17611251RESULT

  • 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.

    PMID: 23625132RESULT

  • 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.

    PMID: 22647561RESULT

  • 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.

    PMID: 21092252RESULT

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Mi Hye Park, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 17, 2014

First Posted

December 3, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

KR(1)