Extracorporeal Life Support in Cardiogenic Shock (ECLS-SHOCK)

• ClinicalTrials.gov Identifier: NCT03637205
• Recruitment Status: Active, not recruiting
• First Posted: August 17, 2018
• Last Update Posted: September 29, 2023
• Sponsor: Helios Health Institute GmbH
• Collaborators: Heart Center Leipzig - University Hospital; IHF GmbH - Institut für Herzinfarktforschung
• Information provided by (Responsible Party): Helios Health Institute GmbH

Tracking Information

• First Submitted Date: August 13, 2018
• First Posted Date: August 17, 2018
• Last Update Posted Date: September 29, 2023
• Actual Study Start Date: June 20, 2019
• Actual Primary Completion Date: December 23, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2018)

30-day mortality [ Time Frame: 30 days ]

30-day all-cause death after randomization according to the intention-to-treat principle

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2018)

• 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.

Original Secondary Outcome Measures (submitted: August 15, 2018)

• 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 [ Time Frame: 12 months ]
  The EQ-5D-5L consists of 2 scales: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The 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. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and '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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Myocardial Infarction
• Cardiogenic Shock

Intervention

• 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.

Study Arms

• Experimental: ECLS
  PCI (or CABG) plus medical treatment + ECLS
  Interventions:

  • Procedure: ECLS insertion
  • Other: Revascularisation and optimal medical treatment
• Active Comparator: No ECLS
  PCI (or CABG) plus medical treatment
  Intervention: Other: Revascularisation and optimal medical treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 15, 2018): 420
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 23, 2023
• Actual Primary Completion Date: December 23, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03637205
• Other Study ID Numbers: HRC[045584]
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Helios Health Institute GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Helios Health Institute GmbH
• Original Study Sponsor: Same as current

Collaborators

• Heart Center Leipzig - University Hospital
• IHF GmbH - Institut für Herzinfarktforschung

Investigators

• Principal Investigator: Holger Thiele, MD; Director, Department of Cardiology, Heart Center Leipzig

• PRS Account: Helios Health Institute GmbH
• Verification Date: September 2023