. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods
Exclusion criteria
. Age \< 18 years
. Pregnancy
. Anticipated support duration \<24 h
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an observational study just collecting data on hemodynamic measurements like cardiac output and blood pressure, does participating change my actual treatment plan for cardiogenic shock in any way, or am I receiving whatever care the team already thinks is best for me?
2This trial is measuring things like pulmonary artery pressure and mixed venous saturation — does that mean I would need additional monitoring lines or catheters inserted that I wouldn't otherwise have, and what risks does that add given how sick I already am?
3Because this study has no assigned phase and is purely observational, what does that mean for what we already know — or don't know — about the Impella RT device being used in my care?
4Since cardiogenic shock is a medical emergency, how would the team get my consent to participate, and do I or my family have enough time to make a thoughtful decision about whether this is right for me?
5Are there standard-of-care monitoring or treatment approaches for cardiogenic shock that would give me the same hemodynamic information without being part of a research study, and how do those compare to what this trial involves?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection of hemodynamic parameters (Cardiac Output in l/min)
Timeframe: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
2
Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)
Timeframe: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
3
Collection of hemodynamic parameters (Mixed Venous Saturation in %)
Timeframe: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
4
Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )
Timeframe: From Impella insertion unitl Impella support is permanently weaned, on average 2 days