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

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ClinicalTrials.gov Identifier: NCT02682615
Recruitment Status : Withdrawn (Due to problems regarding methodology.)
First Posted : February 15, 2016
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jochen Renner, University Hospital Schleswig-Holstein

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).

Condition or disease
Cardiac Output

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cardiac Output Monitoring System (esCCO™) in Comparison to Transcardiopulmonal Thermodilution Technique (PiCCO®) in Critically Ill Patients Within Interdisciplinary Surgical Intensive Care Units
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 1, 2017

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



Primary Outcome Measures :
  1. Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®) [ Time Frame: through study completion, an average of 1 year ]
    Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)


Secondary Outcome Measures :
  1. Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease) [ Time Frame: through study completion, an average of 1 year ]
    Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The aim of this study is the estimation of the agreement between esCCO™ and the transcardiopulmonal thermodilution technique (PiCCO®) using Bland-Altman-treatment. The 95%-confidence interval of the limits of agreement was selected for the design of the number of cases. At a number of cases by 100 you will get the width of 0,68 s (s: standard deviation of the differences of the measurement techniques). This is reasonable for the question (Bland and Altman 1986, you have to compare the recommendation of Bland: https://www.users.york.ac.uk/~mb55/meas/sizemeth.htm).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682615


Locations
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Germany
GERMANY - Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24109
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Principal Investigator: Jochen Renner, PD Dr. med University Hospital Schleswig-Holstein
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Responsible Party: Dr. Jochen Renner, PD Dr., University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02682615    
Other Study ID Numbers: A138-15
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Jochen Renner, University Hospital Schleswig-Holstein:
Cardiac Index
Noninvasive
esCCO
PiCCO
Thermodilution
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes