Transpulmonary Thermodilution Measurements in Patients Wi... | NCT02035007

Studies
Transpulmonary Thermodilution Measurements in Patients With Heart Diseases

NCT02035007

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jun 26, 2015Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Heart Diseases

Interventions

PiCCO Catheter (Pulsiocath 5F)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 2, 2009

First Submission Date that Met QC Criteria

Jan 10, 2014

First Posted Date

Jan 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2015

Last Update Posted Date

Jun 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PiCCO Catheter (Pulsiocath 5F)	Device	Measuring of PiCCO derived values	LV-EF > 50%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Maggiorini, Prof MD	University Hospital Zurich, Medical Intensive Care Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Intensive Care Unit, University Hospital of Zurich		Zurich	Canton of Zurich	8091	Switzerland