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Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

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ClinicalTrials.gov Identifier: NCT02035007
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Heart Diseases Device: PiCCO Catheter (Pulsiocath 5F) Phase 4

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?
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transpulmonary Thermodilution Measurements in Patients With Heart Diseases
Study Start Date : July 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035007


Locations
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Switzerland
Medical Intensive Care Unit, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Marco Maggiorini, Prof MD University Hospital Zurich, Medical Intensive Care Unit
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02035007    
Other Study ID Numbers: Version 2, 17.04.09 / EK1649
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases