Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Heart Diseases Clinical Trial

Official title:

Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035007
• Other study ID #: Version 2, 17.04.09 / EK1649
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2009
• Last updated: June 25, 2015
• Start date: July 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Switzerland	Medical Intensive Care Unit, University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output, Preload values (GEDV)	Outcome measure is obtained during PiCCO measurement and left/right heart catherization, respectively ("point-of-care" measurement). There is no follow-up examination thereafter.	Day 1 only	No