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OpenTrials
Completed

NCT Number: NCT02306018

Evaluation of EV1000™/volumeView™ for Cardiac Output Monitoring in 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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

EV1000™/volumeView™

Device

Primary outcomes

  1. cardiac output

    Time frame: intraoperative

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

Secondary outcomes

  1. systemic vascular resistance

    Time frame: intraoperative

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

  2. stroke volume variability

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

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

  3. stroke volume

    Time frame: intraoperative

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

  4. ejection fraction

    Time frame: intraoperative

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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2014
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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