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

June 11, 2019 updated by: Dr. Jochen Renner, University Hospital Schleswig-Holstein

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

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).

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24109
        • GERMANY - Universitätsklinikum Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Jochen Renner, PD Dr. med, University Hospital Schleswig-Holstein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A138-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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