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

NCT ID: NCT02682615

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2017-12-01

Brief 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).

Detailed 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.

Conditions

Cardiac Output

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

requirement of norepinephrine

requirement of norepinephrine \<0,1 µg/kgKG/min versus ≥0,1 µg/kgKG/min

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jochen Renner

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jochen Renner, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

GERMANY - Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

A138-15

Identifier Type: -

Identifier Source: org_study_id