ECLS-SHOCK: Extracorporeal Life Support in Cardiogenic Shock
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ECLS PCI (or CABG) plus medical treatment + ECLS |
Procedure: ECLS insertion
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
Other: Revascularisation and optimal medical treatment
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
|
| Active Comparator: No ECLS PCI (or CABG) plus medical treatment |
Other: Revascularisation and optimal medical treatment
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
|
Outcome Measures
Primary Outcome Measures
- 30-day mortality [30 days]
30-day all-cause death after randomization according to the intention-to-treat principle
Secondary Outcome Measures
- Time to death within 6 and 12 months follow-up [6 and 12 months]
- Length of mechanical ventilation [0 to 10 days]
- Time to hemodynamic stabilization [0 to 10 days]
- Duration of catecholamine therapy [0 to 10 days]
- Serial creatinine-level and creatinine-clearance [0 to 10 days from time of randomization until stabilization]
Creatinine-clearance (Cockcroft-Gault-Formula)
- Length of ICU stay [0 to 11 days]
- Length of hospital stay [0 to 14 days]
- Serial SAPS-II score [0 to 11 days]
- Mean and area under the curve of arterial lactate [0 to 14 days]
- Acute renal failure requiring renal replacement therapy [0 to 14 days]
- Cerebral performance category (CPC) [30 days, 6 and 12 months]
- Cardiovascular mortality [6 and 12 months]
- Hospitalization for heart failure [6 and 12 months]
- Recurrent infarction [30 days, 6 and 12 months]
- Repeat revascularization (PCI or CABG) [30 days, 6 and 12 months]
- Status of Quality of life measured by EQ-5D-5L descriptive system [12 months]
The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems expressed by 1-digit-numbers ranging from 1 (extreme problems) to 5 (no problems). The toal score ranges from 0-15 where 15 is the worst score.
- Status of Quality of life measured by EQ VAS [12 months]
The EuroQol Group visual analogue scale (EQ VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the maximum 100 is labelled 'The best health you can imagine' and the minimum 0 is labelled 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herzzentrum Leipzig | Leipzig | Germany |
Sponsors and Collaborators
- Leipzig Heart Institute GmbH
- Heart Center Leipzig - University Hospital
- IHF GmbH - Institut für Herzinfarktforschung
Investigators
- Principal Investigator: Holger Thiele, MD, Director, Department of Cardiology, Heart Center Leipzig
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HRC[045584]