Observational study on cardiac output measurement in patients with cardiogenic shock
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Abiomed Inc. · NCT06308055
This study is testing new ways to measure how well the heart is pumping in critically ill patients using special devices to see if it can help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abiomed Inc. (industry) |
| Locations | 1 site (Basel) |
| Trial ID | NCT06308055 on ClinicalTrials.gov |
What this trial studies
This study aims to develop algorithms for determining cardiac output by synchronously acquiring hemodynamic data from pulmonary artery catheters and Impella devices. It focuses on patients receiving intensive care management with Impella support, utilizing both continuous and discontinuous cardiac output measurement methods. The goal is to explore non-invasive alternatives to traditional hemodynamic monitoring, potentially improving patient management in critical care settings.
Who should consider this trial
Good fit: Ideal candidates are adults with ongoing or planned intensive care management requiring Impella support and cardiac output measurement.
Not a fit: Patients under 18 years, pregnant individuals, or those expected to require support for less than 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive monitoring techniques for patients with cardiogenic shock, enhancing patient safety and comfort.
How similar studies have performed: While similar approaches to hemodynamic monitoring have been explored, this specific algorithm development for non-invasive measurement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ongoing or planned intensive care management with Impella support 2. Presence or planned placement of a cardiac output measurement 1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement) 2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods Exclusion Criteria: 1. Age \< 18 years 2. Pregnancy 3. Anticipated support duration \<24 h
Where this trial is running
Basel
- Universitätsspital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Alexander Kersten, MD — Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
- Study coordinator: Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
- Email: agoetzenich@abiomed.com
- Phone: +49 241 8860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiogenic Shock