Cardiac Failure AcuteNCT06918301
Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardiac Surgery Patients.
An observational study of Cardiac Failure Acute and Hemodynamic Monitoring, run by Karlsburg Hospital at 1 site in Germany.
Trial summary
A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery: 1. Pulmonary artery catheter 2. Flo Trac 3. Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Failure Acute, Hemodynamic Monitoring
- What is being tested?
- Measurement of cardiac performance
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients after cardiac surgery requirering a pulmonary artery catheter
Who may be able to join
- Patient after cardiac surgery with pulmonary artery catheter
Who cannot join
- Hemodynamic instability, no consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Anästhesiologie und Intensivmedizin, Klinikum Karlsburg
Karlsburg, 17495
Matthias Heringlake, 004938355700
About this study
A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery:
- Pulmonary artery catheter
- Flo Trac
- Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients.
- Conditions
- Cardiac Failure Acute, Hemodynamic Monitoring
- Being tested
- Measurement of cardiac performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of cardiac performanceDiagnostic test
Measurement of cardiac performance by different devices
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume index
stroke volume index
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Mar 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Failure AcuteStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlsburg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Matthias Heringlake, Karlsburg Hospital
- Investigators
- Matthias Heringlake, Principal investigator, Head of Department of Anesthesiology and intensive care, Karlsburg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918301
- Sponsor's protocol ID
- KAIKB 2025-1
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardiac Surgery Patients.
- ClinicalTrials.gov ID
- NCT06918301
- Acronym / sponsor ID
- KAIKB 2025-1
- Conditions
- Cardiac Failure Acute, Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karlsburg HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- 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.
A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery:
- Pulmonary artery catheter
- Flo Trac
- Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients after cardiac surgery requirering a pulmonary artery catheter
Key inclusion criteria (1 listed)
- Patient after cardiac surgery with pulmonary artery catheter
Key exclusion criteria (1 listed)
- Hemodynamic instability, no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of cardiac performanceMeasurement of cardiac performance by different devices | Diagnostic test | – |
Primary outcome
stroke volume index
Time frame: 24 hours
stroke volume index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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.
Matthias Heringlake principal investigator
Head of Department of Anesthesiology and intensive care, Karlsburg Hospital
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 Failure Acute and Hemodynamic Monitoring, run by Karlsburg Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Heringlake (Deutschland, heringlake@t-online.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stroke volume index (time frame: 24 hours). 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 9 Apr 2025.