Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

The purpose of this study is to examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical Intensive Care Unit, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

How do PiCCO and PAC (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies?
How do PiCCO hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies?
How does GEDV (global enddiastolic volume) correlate with left ventricles end-diastolic volume (LVEDV) assessed by LV (left ventricle) ventriculography and echocardiography?
How do PiCCO cardiac function variables (GEF [global ejection fraction]; CFI [cardiac function index]) correlate with LV dP/dt max, LVEF (left ventricular ejection fraction) assessed by LV ventriculography and echocardiography, LVFAC (left ventricular fractional area of change), LV stroke work index (LVSWI) and cardiac power (CP)?
How does GEDV compare to LVEDV and left ventricular end-diastolic pressure (LVEDP) as assessed by the pulmonary artery occlusion pressure (PAOP)?
How does right ventricular function influence GEDV, GEF and CFI?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Coronary heart disease without impaired left ventricular function [LV-EF > 50%] (n=10, control group)
Coronary heart disease with impaired left ventricular function [LV-EF < 50%] (n=10)
Dilated cardiomyopathy (n=10),
Aortic valve stenosis (n=10),
Mitral valve regurgitation (n=10),
Diastolic left ventricular dysfunction (n=10) and
Right heart failure (n=10)

Exclusion criteria

Patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included.
Moreover patients not being able to give informed consent are excluded. Even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. A pregnancy test will be performed prior to participating with this study.
The age does not represent an exclusion criterion.

Treatment and study plan

PiCCO Catheter (Pulsiocath 5F)

Device

Measuring of PiCCO derived values

Other names: Pulsiocath 5F, Pulsion Medical Systems, Munich, Germany

Primary outcomes

Cardiac Output, Preload values (GEDV)

Time frame: Day 1 only

Outcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively ("point-of-care" measurement). There is no follow-up examination thereafter.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Jan 14, 2014
Registry last updated: Jun 26, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed