Extracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)

H

Helios Health Institute GmbH

Status

Active, not recruiting

Conditions

Cardiogenic Shock
Acute Myocardial Infarction

Treatments

Procedure: ECLS insertion
Other: Revascularisation and optimal medical treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03637205
HRC[045584]

Details and patient eligibility

About

The aim of the study is to examine whether treatment with extracorporeal life support (ECLS) in addition to revascularization with percutaneous coronary intervention (PCI) or alternatively coronary artery bypass grafting (CABG) and optimal medical treatment is beneficial in comparison to no ECLS in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality

Enrollment

420 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory:

  • Planned revascularization (PCI or alternatively CABG)
  • Systolic blood pressure <90 mmHg >30 min or catecholamines required to maintain pressure >90 mmHg during Systole
  • Signs of impaired organ perfusion with at least one of the following criteria a) Altered mental Status, b) Cold, clammy skin and extremities, c) Oliguria with urine output <30 ml/h
  • Arterial lactate >3 mmol/l
  • Informed consent

Exclusion criteria

  • Resuscitation >45 minutes
  • Mechanical cause of cardiogenic shock
  • Onset of shock >12 h
  • Severe peripheral artery disease with impossibility to insert ECLS cannulae
  • Age <18 years or age >75 years
  • Shock of other cause (bradycardia, sepsis, hypovolemia, etc.)
  • Other severe concomitant disease with limited life expectancy <6 months
  • Pregnancy
  • Participation in another trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

420 participants in 2 patient groups

ECLS
Experimental group
Description:
PCI (or CABG) plus medical treatment + ECLS
Treatment:
Other: Revascularisation and optimal medical treatment
Procedure: ECLS insertion
No ECLS
Active Comparator group
Description:
PCI (or CABG) plus medical treatment
Treatment:
Other: Revascularisation and optimal medical treatment

Trial contacts and locations

1

Loading...

Central trial contact

Holger Thiele, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems