ECLS insertion
ProcedureAfter 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
Completed
NCT Number: NCT03637205
Extracorporeal Life Support in Cardiogenic Shock
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
Completed
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Universitätsklinikum Aachen, Aachen, Germany
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Revascularisation and optimal medical treatment
OtherAfter diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
Primary outcomes
-
30-day mortality
Time frame: 30 days
30-day all-cause death after randomization according to the intention-to-treat principle
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
Time frame: 0 to 10 days from time of randomization until stabilization
Creatinine-clearance (Cockcroft-Gault-Formula)
-
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
-
Cerebral performance category (CPC)
Time frame: 30 days, 6 and 12 months
-
Cardiovascular mortality
Time frame: 6 and 12 months
-
Hospitalization for heart failure
Time frame: 6 and 12 months
-
Recurrent infarction
Time frame: 30 days, 6 and 12 months
-
Repeat revascularization (PCI or CABG)
Time frame: 30 days, 6 and 12 months
-
Status of Quality of life measured by EQ-5D-5L descriptive system
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Helios Health Institute GmbH
Other
Collaborators
- Heart Center Leipzig - University Hospital
- IHF GmbH - Institut für Herzinfarktforschung
Registry information
Official study 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
Acronym: ECLS-SHOCK
Important dates
- Study start
- 2019
- Primary completion
- 2022
- Study completion
- 2024
- First posted
- Aug 17, 2018
- Registry last updated
- Dec 13, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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