Cardiac OutputNCT02682615
Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients Within ICU
An observational study of Cardiac Output, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team
Who cannot join
- atrial fibrillation
- cardiac arrhythmias
- cardiac pacemaker
- intraaortic counterpulsation
- pericardial tamponade
- age < 18 years
- missing or incorrect patient consent form
Trial locations and contacts
1 site in 1 country.
Germany1 site
GERMANY - Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24109
About this study
Official title: 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).
Read the 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
- Keywords
- Cardiac Index, Noninvasive, esCCO, PiCCO, Thermodilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| requirement of norepinephrine | requirement of norepinephrine <0,1 µg/kgKG/min versus ≥0,1 µg/kgKG/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®)
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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®)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start1 Aug 2017 (estimated)
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Why it stopped: Due to problems regarding methodology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jochen Renner, University Hospital Schleswig-Holstein
- Investigators
- Jochen Renner, PD Dr. med, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682615
- Sponsor's protocol ID
- A138-15
- Status last verified
- Jun 2019
- First submitted
- 12 Jan 2016
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Monitoring System (esCCO™) in Comparison to Transcardiopulmonal Thermodilution Technique (PiCCO®) in Critically Ill Patients Within Interdisciplinary Surgical Intensive Care Units
- ClinicalTrials.gov ID
- NCT02682615
- Acronym / sponsor ID
- A138-15
- Conditions
- Cardiac Output
- Keywords
- Cardiac Index, Noninvasive, esCCO, PiCCO, Thermodilution
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to problems regarding methodology.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| requirement of norepinephrine | – | –requirement of norepinephrine <0,1 µg/kgKG/min versus ≥0,1 µg/kgKG/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team
Key exclusion criteria (7 listed)
- atrial fibrillation
- cardiac arrhythmias
- cardiac pacemaker
- intraaortic counterpulsation
- pericardial tamponade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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®)
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Renner, PD Dr. med principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.