Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients Within ICU

Cardiac Output Clinical Trial

Official title:

Cardiac Output Monitoring System (esCCO™) in Comparison to Transcardiopulmonal Thermodilution Technique (PiCCO®) in Critically Ill Patients Within Interdisciplinary Surgical Intensive Care Units

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02682615
• Other study ID #: A138-15
• Status: Withdrawn
• Start date: August 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: June 2019
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease - APACHE II score).

Description:

The measurements have to estimate the agreement of esCCO™ and PiCCO® related to the cardiac output (cardiac index). It should consult a comparison of methods between a complete non-invasive cardiac output monitoring method (esCCO™) and the transcardiopulmonal thermodilution technique (PiCCO®). The accuracy shall carve out as well as the power of agreement of both measurement methods.

It takes two simultaneous measurements at a time of critically ill patients at interdisciplinary surgical intensive care units. Furthermore the force of the major variables (1. requirement of norepinephrine and 2. APACHE II-score) to the estimators shall be realized.

esCCO™ vs. (PiCCO®)

This research shall include 100 patients which have to undergo a complex intensive care treatment within predefined therapy intentions.

During a daily screening within the interdisciplinary surgical intensive care units of the Universitätsklinikum Schleswig-Holstein, Campus Kiel it will be opted for the inclusion of the patients.

Points of time x [x ε M and M = {1, 2, 3, 4}] - two test series (measurement 1 and 2).

According to the ability of the patient to the research the predefined point of time number 1 will be supposed (point of time number 1: inclusion criterium). The predefined point of time number 2 will be supposed if the therapy concept is planned or changed. The point of time number 3 is defined as the re-evaluation in the course of changed therapy conceptions. If the medical practitioner team decides to renounce the PiCCO-system, the predefined point of time number 4 has arrived.

The requirement of norepinephrine will be registered in every measurement (1 and 2). The APACHE II-score will be surveyed each point of time x (see above).

The remaining treatment of the patients will be performed in the conventional way by the medical practitioner team within the interdisciplinary surgical intensive care units.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team

Exclusion Criteria:

• atrial fibrillation

• cardiac arrhythmias

• cardiac pacemaker

• intraaortic counterpulsation

• pericardial tamponade

• age < 18 years

• missing or incorrect patient consent form

Related Conditions & MeSH terms

• Cardiac Output
• Critical Illness

Locations

Country	Name	City	State
Germany	GERMANY - Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®)	Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)	through study completion, an average of 1 year
Secondary	Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease)	Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)	through study completion, an average of 1 year