Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

Detailed Description

– 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?

Interventions

  • Device: PiCCO Catheter (Pulsiocath 5F)
    • Measuring of PiCCO derived values

Arms, Groups and Cohorts

  • Experimental: LV-EF > 50%
    • PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function [LV-EF > 50%]

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marco Maggiorini, Prof MD, Principal Investigator, University Hospital Zurich, Medical Intensive Care Unit

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