Extracorporeal Life Support in Cardiogenic Shock

Helios Health Institute GmbH420 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

Acute Myocardial Infarction Cardiogenic Shock

Interventions

ECLS insertionPROCEDURE

After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. ECLS insertion should be performed preferably before revascularization

Revascularisation and optimal medical treatmentOTHER

After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

30-day mortality

30-day all-cause death after randomization according to the intention-to-treat principle

Time frame: 30 days

Secondary Outcomes

Time to death within 6 and 12 months follow-up

Time frame: 6 and 12 months

Length of mechanical ventilation

Time frame: 0 to 10 days

Time to hemodynamic stabilization

Time frame: 0 to 10 days

Duration of catecholamine therapy

Time frame: 0 to 10 days

Serial creatinine-level and creatinine-clearance

Creatinine-clearance (Cockcroft-Gault-Formula)

Time frame: 0 to 10 days from time of randomization until stabilization

Length of ICU stay

Time frame: 0 to 11 days

Length of hospital stay

Time frame: 0 to 14 days

Serial SAPS-II score

Time frame: 0 to 11 days

Mean and area under the curve of arterial lactate

Time frame: 0 to 14 days

Acute renal failure requiring renal replacement therapy

Time frame: 0 to 14 days

Data from ClinicalTrials.gov

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...and 36 more locations