Clinical trial NCT03637205: Extracorporeal Life Support in Cardiogenic Shock
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Cardiogenic Shock
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
name: IHF GmbH - Institut für Herzinfarktforschung
First posted: 2018-08-17
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Time to death within 6 and 12 months follow-up
timeFrame: 6 and 12 months
measure: Length of mechanical ventilation
timeFrame: 0 to 10 days
measure: Time to hemodynamic stabilization
timeFrame: 0 to 10 days
measure: Duration of catecholamine therapy
timeFrame: 0 to 10 days
measure: Serial creatinine-level and creatinine-clearance
timeFrame: 0 to 10 days from time of randomization until stabilization
measure: Length of ICU stay
timeFrame: 0 to 11 days
measure: Length of hospital stay
timeFrame: 0 to 14 days
measure: Serial SAPS-II score
timeFrame: 0 to 11 days
measure: Mean and area under the curve of arterial lactate
timeFrame: 0 to 14 days
measure: Acute renal failure requiring renal replacement therapy
timeFrame: 0 to 14 days
measure: Cerebral performance category (CPC)
timeFrame: 30 days, 6 and 12 months
measure: Cardiovascular mortality
timeFrame: 6 and 12 months
measure: Hospitalization for heart failure
timeFrame: 6 and 12 months
measure: Recurrent infarction
timeFrame: 30 days, 6 and 12 months
measure: Repeat revascularization (PCI or CABG)
timeFrame: 30 days, 6 and 12 months
measure: Status of Quality of life measured by EQ-5D-5L descriptive system
timeFrame: 12 months
measure: Status of Quality of life measured by EQ VAS
timeFrame: 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn GmbH Klinikum Am Plattenwald
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik Forschungsgesellschaft mbH
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, CBF Medizinische Klinik für Kardiologie
city: Berlin
country: Germany
facility: BG Klinikum Unfallkrankenhaus Berlin gGmbH
city: Dortmund
country: Germany
facility: St-Johannes-Hospital Klinik für Innere Medizin I
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt 3. Medizinische Klinik
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus GmbH Klinik für Kardiologie und Angiologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR) Westdeutsches Herz- und Gefäßzentrum Essen
city: Frankfurt Höchst
country: Germany
facility: Klinikum Frankfurt Höchst
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt ZIM - Med. Klink III - Kardiologie
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen und Innere Medizin III - internistische Intensivmedizin
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Klinik für Kardiologie und Pneumologie
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin III
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Kardiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes Klinik für Innere Medizin III
city: Jena
country: Germany
facility: Uniklinikum Jena Klinik für Innere Medizin I
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld
city: Köln
country: Germany
facility: Universitätsklinikum Köln Klinik III für Innere Medizin
city: Langen
country: Germany
facility: Asklepios Kliniken Langen-Seligenstadt GmbH
city: Leipzig
country: Germany
facility: Universität Leipzig Klinik und Poliklinik für Kardiologie
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Lübeck
country: Germany
facility: Universitäres Herzzentrum Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin)
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Mönchengladbach
country: Germany
facility: Kliniken Mariahilf GmbH
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin II
city: Reutlingen
country: Germany
facility: Kreiskliniken Reutlingen GmbH
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock Zentrum für Innere Medizin
city: Siegburg
country: Germany
facility: Helios Klinikum Siegburg
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm Klinik für Innere Medizin II / Kardiologie
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Klinik Innere MED I: Kardiologie und konserv. Intensivmedizin
city: Winnenden
country: Germany
facility: Rems-Murr-Kliniken Winnenden Abteilung für Kardiologie
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal Medizinische Klinik 3 - Kardiologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik I
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Director, Department of Cardiology, Heart Center Leipzig
name: Holger Thiele, MD
role: PRINCIPAL_INVESTIGATOR
References: