Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO

Universitätsklinikum Hamburg-Eppendorf

Status

Enrolling

Conditions

Cardiogenic Shock

Treatments

Device: VA-ECMO

Device: Impella

Study type

Interventional

Funder types

Other

Identifiers

NCT05577195

UNLOAD ECMO

Details and patient eligibility

About

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.

Full description

In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality .

The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.

Enrollment

198 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.