Extracorporeal Life Support in Cardiogenic Shock
ECLS-SHOCK
Prospective Randomized Multicenter Study Comparing Extracorporeal Life Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Revascularization
1 other identifier
interventional
420
2 countries
46
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedStudy Start
First participant enrolled
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2024
CompletedDecember 13, 2024
December 1, 2024
3.5 years
August 13, 2018
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
30-day mortality
30-day all-cause death after randomization according to the intention-to-treat principle
30 days
Secondary Outcomes (17)
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
- +12 more secondary outcomes
Study Arms (2)
ECLS
EXPERIMENTALPCI (or CABG) plus medical treatment + ECLS
No ECLS
ACTIVE COMPARATORPCI (or CABG) plus medical treatment
Interventions
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
After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Universitätsklinikum Aachen
Aachen, 52074, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, 99438, Germany
SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald
Bad Friedrichshall, 74177, Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, 61231, Germany
Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
Berlin, 12203, Germany
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, 12683, Germany
Universitätsklinikum Köln Klinik III für Innere Medizin
Cologne, 50937, Germany
St-Johannes-Hospital Klinik für Innere Medizin I
Dortmund, 44137, Germany
Technische Universität Dresden
Dresden, 01062, Germany
Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, 40225, Germany
Helios Klinikum Erfurt 3. Medizinische Klinik
Erfurt, 99089, Germany
Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie
Essen, 45138, Germany
Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen
Essen, 45147, Germany
Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie
Frankfurt, 60590, Germany
Klinikum Frankfurt Höchst
Frankfurt Höchst, 65929, Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Gießen
Giessen, 35392, Germany
Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie
Göttingen, 37075, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III
Halle, 06120, Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, 20099, Germany
Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitätsklinikum des Saarlandes Klinik für Innere Medizin III
Homburg, 66421, Germany
Uniklinikum Jena Klinik für Innere Medizin I
Jena, 07747, Germany
Klinikum Kassel GmbH
Kassel, 34125, Germany
Helios Klinikum Krefeld
Krefeld, 47805, Germany
Asklepios Kliniken Langen-Seligenstadt GmbH
Langen, 63225, Germany
Universität Leipzig Klinik und Poliklinik für Kardiologie
Leipzig, 04103, Germany
Herzzentrum Leipzig
Leipzig, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063, Germany
Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)
Lübeck, 23538, Germany
Universitätsmedizin Mannheim
Mannheim, 68167, Germany
Kliniken Mariahilf GmbH
Mönchengladbach, 41063, Germany
Klinikum Nürnberg
Nuremberg, 90419, Germany
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II
Regensburg, 93053, Germany
Kreiskliniken Reutlingen GmbH
Reutlingen, 72764, Germany
Universitätsmedizin Rostock Zentrum für Innere Medizin
Rostock, 18057, Germany
Helios Klinikum Siegburg
Siegburg, 53721, Germany
Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie
Ulm, 89081, Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin
Wiesbaden, 65199, Germany
Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie
Winnenden, 71364, Germany
Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie
Wuppertal, 42117, Germany
Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
Würzburg, 97080, Germany
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
Related Publications (3)
Thevathasan T, Alyahoud M, Freund A, Akin I, Fichtlscherer S, Zeymer U, Feistritzer HJ, Poss J, Jobs A, Rossberg M, Jung C, Skurk C, Rassaf T, Ouarrak T, Schneider S, Thiele H, Desch S. Extracorporeal Membrane Oxygenation Complications Are Not Causal for Mortality in Patients With Infarct-Related Cardiogenic Shock: A Mediation Analysis of the Extracorporeal Life Support in Infarct-Related Cardiogenic Shock (ECLS-SHOCK) Trial. Crit Care Med. 2025 Dec 1;53(12):e2607-e2617. doi: 10.1097/CCM.0000000000006893. Epub 2025 Oct 17.
PMID: 41114622DERIVEDFeistritzer HJ, Zeymer U, Ouarrak T, Akin I, Rassaf T, Lehmann R, Eitel I, Seidler T, Skurk C, Clemmensen P, Voigt I, Seyfarth M, Linke A, Tigges E, Jung C, Lauten P, Poss J, Schneider S, Desch S, Freund A, Thiele H; ECLS-SHOCK Investigators. Different Mechanical Circulatory Support Strategies for Infarct-Related Cardiogenic Shock: A Subanalysis of the ECLS-SHOCK Trial. JACC Cardiovasc Interv. 2025 Mar 24;18(6):691-701. doi: 10.1016/j.jcin.2024.12.010.
PMID: 40139846DERIVEDThiele H, Zeymer U, Akin I, Behnes M, Rassaf T, Mahabadi AA, Lehmann R, Eitel I, Graf T, Seidler T, Schuster A, Skurk C, Duerschmied D, Clemmensen P, Hennersdorf M, Fichtlscherer S, Voigt I, Seyfarth M, John S, Ewen S, Linke A, Tigges E, Nordbeck P, Bruch L, Jung C, Franz J, Lauten P, Goslar T, Feistritzer HJ, Poss J, Kirchhof E, Ouarrak T, Schneider S, Desch S, Freund A; ECLS-SHOCK Investigators. Extracorporeal Life Support in Infarct-Related Cardiogenic Shock. N Engl J Med. 2023 Oct 5;389(14):1286-1297. doi: 10.1056/NEJMoa2307227. Epub 2023 Aug 26.
PMID: 37634145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holger Thiele, MD
Director, Department of Cardiology, Heart Center Leipzig
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 17, 2018
Study Start
June 20, 2019
Primary Completion
December 23, 2022
Study Completion
September 2, 2024
Last Updated
December 13, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share