Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

NCT02035007 | Completed Phase 4 DMC

• 1 other identifier: Version 2, 17.04.09 / EK1649
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LV-EF > 50%

EXPERIMENTAL

PiCCO catheter analysis of patients with coronary heart disease without impaired left ventricular function \[LV-EF \> 50%\]

Device: PiCCO Catheter (Pulsiocath 5F)

Interventions

PiCCO Catheter (Pulsiocath 5F) DEVICE

Measuring of PiCCO derived values

Also known as: Pulsiocath 5F, Pulsion Medical Systems, Munich, Germany

LV-EF > 50%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Medical Intensive Care Unit, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Marco Maggiorini, Prof MD

  University Hospital Zurich, Medical Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: January 14, 2014
• Study Start: July 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

CH (1)