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Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

This study has been completed.
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: October 2, 2009
Last updated: June 25, 2015
Last verified: June 2015
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.

Condition Intervention Phase
Heart Diseases Device: PiCCO Catheter (Pulsiocath 5F) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome 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.

Enrollment: 70
Study Start Date: July 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LV-EF > 50%
PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function [LV-EF > 50%]
Device: PiCCO Catheter (Pulsiocath 5F)
Measuring of PiCCO derived values
Other Name: Pulsiocath 5F, Pulsion Medical Systems, Munich, Germany

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?

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT02035007

Medical Intensive Care Unit, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Principal Investigator: Marco Maggiorini, Prof MD University Hospital Zurich, Medical Intensive Care Unit
  More Information

Responsible Party: University of Zurich Identifier: NCT02035007     History of Changes
Other Study ID Numbers: Version 2, 17.04.09 / EK1649
Study First Received: October 2, 2009
Last Updated: June 25, 2015

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases processed this record on August 17, 2017