Condition category
Circulatory System
Date applied
30/11/2019
Date assigned
15/12/2019
Last edited
13/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
In critically ill patients it is important to closely monitor aspects of blood flow (haemodynamic parameters) such as amount of blood flow, the blood pressure, the heart output. The technique used to measure this is known as transpulmonary thermodilution and pulse contour analysis. The measurements can be performed using a tube attached to sensory equipment inserted into a large blood vessel (central venous catheter). Precise and reliable measurements are important. At the present time there are two devices which are routinely using transpulmonary thermodilution and pulse contour analysis to determine extended haemodynamic parameters: PiCCO and EV1000 monitoring systems. The aim of this study is to compare the PiCCO and EV1000 for neck vein (jugular) and leg vein (femoral) measurements.

Who can participate?
Patients aged 18 years or above who are being treated in the intensive care unit.

What does the study involve?
In this study EV1000 will be replaced by PiCCO device or vice-versa. During the exchange of these monitoring systems, measurements will be performed using the jugular and femoral central venous catheter to allow the comparison of both haemodynamic monitoring systems.

What are the possible benefits and risks of participating?
The measurements during the exchange from one to another monitoring system guarantee the reliability of determined parameters and its usefulness for further therapeutic management. As both systems are clinically approved and routinely used, there is no additional risk by the devices.
The decision for exchange of arterial or central venous/shaldon catheter will be made irrespective of the study according to local standards. The most common complication of replacement of arterial or central venous line are vascular-, pulmonary-, cardiac-complications, catheter dysfunction or infection.

Where is the study run from?
Klinik und Poliklinik für Innere Medizin II am Klinikum rechts der Isar, Technische Universität München, Germany

When is the study starting and how long is it expected to run for?
January 2017 to March 2017

Who is funding the study?
Klinik und Poliklinik für Innere Medizin II am Klinikum rechts der Isar, Technische Universität München, Germany

Who is the main contact?
Dr Alexander Herner
alexander.herner@mri.tum.de
Prof. Wolfgang Huber
wolfgang.huber@mri.tum.de





The usefulness of transpulmonary thermodilution (TPTD) for the measurement of extended hemodynamic parameters (e.g. cardiac index (CI), global end-diastolic volume index (GEDVI), extra vascular lung water index (EVLWI), pulmonary vascular permeability index (PVPI) and global ejection fraction (GEF)) has been demonstrated in a number of studies. Usually TPTD is performed by indicator injection via the jugular or subclavian vein. However, under certain circumstances, superior vena cava access is not feasible. In these cases, femoral access can be used for measurement. Femoral Indicator bolus injections using PiCCO®-device have demonstrated significant overestimation particularly of GEDVI due to the additional volume of the inferior vena cava. This overestimation was corrected by formula and integrated in the newest algorithm used by PiCCO®-device. Recently, in addition to the PiCCO® device, another commercially available device for TPTD has been introduced, EV1000/VolumeView® which uses similar methodologies and algorithms as the PiCCO® device. However, there are no systematic data on the impact of femoral indicator injection for the EV-1000® device
Therefore, we compared the agreement of hemodynamic parameters sequentially derived by femoral as well as jugular indicator injection using the EV-1000® and the PiCCO® device in patients equipped with both jugular and femoral venous access.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexander Herner

ORCID ID

http://orcid.org/0000-0003-3905-9280

Contact details

Klinikum rechts der Isar
II. Medizinische Klinik
Ismaningerstrasse 22
München
81675
Germany
+49 (0)8941409334
alexander.herner@mir.tum.de

Type

Scientific

Additional contact

Prof Wolfgang Huber

ORCID ID

Contact details

Klinikum rechts der Isar
II. Medizinische Klinik
Ismaningerstrasse 22
München
81675
Germany
+49 (0)8941402214
wolfgang.huber@mri.tum.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EV-1000

Study information

Scientific title

Comparison of global end-diastolic volume index derived from jugular and femoral indicator injection in patients equipped with both a PiCCO-2 and an EV-1000-device

Acronym

Study hypothesis

Are parameters derived by PiCCO and EV-1000-device comparable?

Ethics approval

Approved 28/06/2012, Ethikkommission; Fakultät für Medizin; Technische Universität München (Ismaninger Straße 22, 81675, München, Germany; +49 4140-7737; ethikkommission@mri.tum.de), ref: 5384/12

Study design

Prospective observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Critically ill patients with the need for extended hemodynamic monitoring

Intervention

First, only patients already equipped with a central venous catheter/dialysis catheter and PiCCO or EV-1000 monitoring system will be enrolled in this study.

Second, the treating physician (not involved in the study) performs the change of the CVC and the arterial line in patients with pre-existing and continuous need for advanced haemodynamic (transpulmonary thermodilution)-monitoring. This decision will be made irrespective of the study according to local standards. During the change of catheters, measurements with PiCCO- and EV-1000-device will be performed. A measurement consists of a triplicate injection of indicator (15 ml ice cold 0,9% saline solution). Duration of the measurement is around 15 minutes. There is no other intervention or follow up.

Intervention type

Device

Phase

Not Applicable

Drug names

PiCCO® device
EV-1000® device

Primary outcome measure

Global end-diastolic volume (index) measured using PiCCO and EV1000

Secondary outcome measures

Measured using PiCCO and EV1000
1. Cardiac output/index
2. Cardiac function index
3. Global ejection fraction
4. Extravascular lung water index
5. Pulmonary vascular permeability index
6. Central venous pressure
7. Systolic volume variation
8. Pulse pressure variation

Overall trial start date

01/08/2016

Overall trial end date

31/03/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients treated on the intensive care unit
2. Critically ill patients
3. Patients with the need of a change of CVC and arterial line in patients with pre-existing and continuing need for TPTD-monitoring
4. Hemodynamic stable patients without vasopressors or with a constant vasopressor-dosage

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Pregnant
2. Younger than 18 years old

Recruitment start date

25/01/2017

Recruitment end date

31/03/2017

Locations

Countries of recruitment

Germany

Trial participating centre

Klinikum rechts der Isar, Technische Universität München
Ismaningerstraße 22
Germany
81675
Germany

Sponsor information

Organisation

Klinikum der Universität München

Sponsor details

Klinik und Poliklinik für Innere Medizin II
Klinikum rechts der Isar
Technischen Universität München
Ismaningerstrasse 22
München
81675
Germany
+49 (0)89 4140-2251
direktion.med2@mri.tum.de

Sponsor type

Hospital/treatment centre

Website

http://www.frauenklinik.med.tum.de/

Funders

Funder type

Hospital/treatment centre

Funder name

Technische Universität München

Alternative name(s)

Technical University of Munich, TUM

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Germany

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/12/2019: Trial’s existence confirmed by Technische Universität München