Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

Phase 4

Completed

• Conditions: Heart Diseases
• Interventions: Device: PiCCO Catheter (Pulsiocath 5F)

• Registration Number: NCT02035007
• Lead Sponsor: University of Zurich

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.

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?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cardiac Output, Preload values (GEDV)	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.

Trial Locations

Locations (1)

Medical Intensive Care Unit, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland