Extracorporeal Life Support in Cardiogenic Shock

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction; Cardiogenic Shock
• Interventions: Procedure: ECLS insertion; Other: Revascularisation and optimal medical treatment

• Registration Number: NCT03637205
• Lead Sponsor: Helios Health Institute GmbH

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2019-06-20
• Primary Completion: 2022-12-23
• Study Completion: 2024-09-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECLS	ECLS insertion	PCI (or CABG) plus medical treatment + ECLS
No ECLS	Revascularisation and optimal medical treatment	PCI (or CABG) plus medical treatment
ECLS	Revascularisation and optimal medical treatment	PCI (or CABG) plus medical treatment + ECLS

Primary Outcome Measures

Name	Time	Method
30-day mortality	30 days	30-day all-cause death after randomization according to the intention-to-treat principle

Secondary Outcome Measures

Name	Time	Method
Acute renal failure requiring renal replacement therapy	0 to 14 days
Hospitalization for heart failure	6 and 12 months
Time to death within 6 and 12 months follow-up	6 and 12 months
Time to hemodynamic stabilization	0 to 10 days
Length of mechanical ventilation	0 to 10 days
Cerebral performance category (CPC)	30 days, 6 and 12 months
Recurrent infarction	30 days, 6 and 12 months
Duration of catecholamine therapy	0 to 10 days
Cardiovascular mortality	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.
Length of ICU stay	0 to 11 days
Serial creatinine-level and creatinine-clearance	0 to 10 days from time of randomization until stabilization	Creatinine-clearance (Cockcroft-Gault-Formula)
Serial SAPS-II score	0 to 11 days
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.
Length of hospital stay	0 to 14 days
Mean and area under the curve of arterial lactate	0 to 14 days

Trial Locations

Locations (46)

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald; 🇩🇪 Bad Friedrichshall, Germany

Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie; 🇩🇪 Berlin, Germany

BG Klinikum Unfallkrankenhaus Berlin gGmbH; 🇩🇪 Berlin, Germany

St-Johannes-Hospital Klinik für Innere Medizin I; 🇩🇪 Dortmund, Germany

Technische Universität Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie; 🇩🇪 Düsseldorf, Germany

Helios Klinikum Erfurt 3. Medizinische Klinik; 🇩🇪 Erfurt, Germany

Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie; 🇩🇪 Essen, Germany

Kerckhoff-Klinik Forschungsgesellschaft mbH; 🇩🇪 Bad Nauheim, Germany

Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen; 🇩🇪 Essen, Germany

Klinikum Frankfurt Höchst; 🇩🇪 Frankfurt Höchst, Germany

Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie; 🇩🇪 Frankfurt, Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin; 🇩🇪 Freiburg, Germany

Universitätsklinikum Gießen; 🇩🇪 Gießen, Germany

Universitätsmedizin Greifswald; 🇩🇪 Greifswald, Germany

Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie; 🇩🇪 Göttingen, Germany

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III; 🇩🇪 Halle (Saale), Germany

Asklepios Kliniken Hamburg GmbH; 🇩🇪 Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

SLK-Kliniken Heilbronn GmbH; 🇩🇪 Heilbronn, Germany

Universitätsklinikum des Saarlandes Klinik für Innere Medizin III; 🇩🇪 Homburg, Germany

Uniklinikum Jena Klinik für Innere Medizin I; 🇩🇪 Jena, Germany

Klinikum Kassel GmbH; 🇩🇪 Kassel, Germany

Helios Klinikum Krefeld; 🇩🇪 Krefeld, Germany

Universitätsklinikum Köln Klinik III für Innere Medizin; 🇩🇪 Köln, Germany

Asklepios Kliniken Langen-Seligenstadt GmbH; 🇩🇪 Langen, Germany

Universität Leipzig Klinik und Poliklinik für Kardiologie; 🇩🇪 Leipzig, Germany

Klinikum der Stadt Ludwigshafen gGmbH; 🇩🇪 Ludwigshafen, Germany

Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin); 🇩🇪 Lübeck, Germany

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Germany

Kliniken Mariahilf GmbH; 🇩🇪 Mönchengladbach, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II; 🇩🇪 Regensburg, Germany

Kreiskliniken Reutlingen GmbH; 🇩🇪 Reutlingen, Germany

Universitätsmedizin Rostock Zentrum für Innere Medizin; 🇩🇪 Rostock, Germany

Helios Klinikum Siegburg; 🇩🇪 Siegburg, Germany

Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie; 🇩🇪 Ulm, Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin; 🇩🇪 Wiesbaden, Germany

Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie; 🇩🇪 Winnenden, Germany

Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie; 🇩🇪 Wuppertal, Germany

Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I; 🇩🇪 Würzburg, Germany

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany