UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ Severe cardiogenic shock due to severe left ventricular dysfunction:
• Systolic blood pressure \<90 mmHg or need for catecholamines to maintain such blood pressure
• Signs of impaired organ perfusion with at least one of the following: altered mental status OR cold, clammy skin OR oliguria with urine output \<30 ml/h
• Arterial lactate \>5 mmol/l
Locations
Other Locations
Germany
University Heart and Vascular Center Hamburg
RECRUITING
Hamburg
Contact Information
Primary
Dirk Westermann, Prof.
d.westermann@uke.de
0049 40 7410 0
Backup
Benedikt Schrage, Dr.
b.schrage@uke.de
Time Frame
Start Date: 2022-11-17
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 198
Treatments
Experimental: Impella + VA-ECMO
Active_comparator: VA-ECMO only
Related Therapeutic Areas
Sponsors
Leads: Universitätsklinikum Hamburg-Eppendorf