Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

Official Title
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Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Conditions
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Heart Diseases

Intervention / Treatment
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* Device: PiCCO Catheter (Pulsiocath 5F)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LV-EF > 50%<br>PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function [LV-EF > 50%] | Device: PiCCO Catheter (Pulsiocath 5F)<br>* Measuring of PiCCO derived values<br>* Other names: Pulsiocath 5F, Pulsion Medical Systems, Munich, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output, Preload values (GEDV) | Outcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively (point-of-care measurement). There is no follow-up examination thereafter. | Day 1 only |