Clinical trial NCT04825015: Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter (VERO Study)
Official title: Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter VERO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
Liver Transplant; Complications
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients undergoing liver transplant at our institution

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.


Eligibility criteria: 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

Primary outcomes:
measure: Precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures
timeFrame: During surgery
measure: Accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures
timeFrame: During surgery
Secondary outcomes:
measure: Correlation
timeFrame: During surgery
measure: Concordance
timeFrame: During surgery
measure: Time of device positioning
timeFrame: During surgery
measure: Device positioning complications
timeFrame: During surgery
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.