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Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

University of Zurich (UZH) logo

University of Zurich (UZH)

Status and phase

Completed
Phase 4

Conditions

Heart Diseases

Treatments

Device: PiCCO Catheter (Pulsiocath 5F)

Study type

Interventional

Funder types

Other

Identifiers

NCT02035007
Version 2, 17.04.09 / EK1649

Details and patient eligibility

About

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.

Full 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?

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

LV-EF > 50%
Experimental group
Description:
PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function \[LV-EF \> 50%\]
Treatment:
Device: PiCCO Catheter (Pulsiocath 5F)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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