Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02035007
First received: October 2, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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: 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 ] [ Designated as safety issue: No ]
    Outcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively ("point-of-care" measurement). There is no follow-up examination thereafter.


Estimated Enrollment: 70
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated 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?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035007

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Medical Intensive Care Unit, University Hospital of Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Daniel Franzen, MD    ++411442551111    daniel.franzen@usz.ch   
Contact: Marco Maggiorini, Prof.    ++411442551111    marco.maggiorini@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Marco Maggiorini, Prof MD University Hospital Zurich, Medical Intensive Care Unit
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02035007     History of Changes
Other Study ID Numbers: Version 2, 17.04.09 / EK1649
Study First Received: October 2, 2009
Last Updated: January 10, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014