Cardiogenic Shock
Conditions
Keywords
Impella
Brief summary
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device
Interventions
DEVICEImpella CP microaxial pump
ramp test
Sponsors
University of Leipzig
Jena University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 91 Years
Healthy volunteers
No
Inclusion criteria
* Cardiogenic shock following acute MI or acute heart failure with * systolic BP \< 90 mm Hg over \> 30 min or inotropes for support of cardiac output and BP with * signs of left heart failure and pulmonary congestion * and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate \>2 mmol/l
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Parameters due to PA catheterisation | Day 1 | Pulmonary capillary Wedge pressure in dependence of Impella pump level |
| Echocardiographic Parameters of left and right heart function | Day 1 | LV- size in dependence of Impella pump level |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORSven Möbius-Winkler, MD
Universityhospital Jena
Outcome results
None listed