Improving outcomes in cardiogenic shock patients using Impella with VA-ECMO
UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial
This study is testing if using an Impella device along with VA-ECMO can help people in cardiogenic shock live longer compared to just using VA-ECMO alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT05577195 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of using an Impella device for active left ventricular unloading in patients experiencing cardiogenic shock while receiving veno-arterial extracorporeal membrane oxygenation (VA-ECMO). It is a prospective, multi-center, randomized controlled trial involving 198 patients who will be assigned to either receive the Impella device alongside VA-ECMO or VA-ECMO alone. The primary goal is to assess the impact of this combined approach on mortality rates within 30 days of treatment. The study builds on previous findings suggesting that this method may reduce mortality in similar patient populations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with severe cardiogenic shock due to left ventricular dysfunction.
Not a fit: Patients with cardiogenic shock from causes other than severe left ventricular dysfunction or those with pre-existing Impella treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower mortality rates in patients suffering from cardiogenic shock.
How similar studies have performed: Previous studies have indicated potential benefits of this approach, but this trial aims to provide more definitive evidence through a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * Post-cardiotomy cardiogenic shock. * Cardiogenic shock due to acute rejection in heart transplant recipients. * Obstructive cardiogenic shock (e.g. cardiogenic shock due to fulminant pulmonary embolism) * Cardiogenic shock due to other causes (e.g. bleeding, hypothermia) * Pre-existing Impella treatment. * Onset of shock \>12 hours. * Mechanical complication of acute myocardial infarction. * Prolonged resuscitation (\>60 minutes). * Severe peripheral artery disease with infeasibility for Impella or veno-arterial extracorporeal membrane oxygenation implantation. * Age \<18 or \>80 years. * Other severe concomitant disease with life expectancy \<6 months. * Participation in another trial with an intervention or pregnancy.
Where this trial is running
Hamburg
- University Heart and Vascular Center Hamburg — Hamburg, Germany (Recruiting)
Study contacts
- Study coordinator: Dirk Westermann, Prof.
- Email: d.westermann@uke.de
- Phone: 0049 40 7410 0
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.