Clinical Trial: ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
Brief Summary: Eligible patients with severe cardiogenic shock will be randomized to one of the two arms: immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial ECMO will be implanted according to the local practice with flow settings to ensure sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group, all other diagnostic and therapeutic procedures will be done according to the current standard of care at the tertiary cardiovascular center, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of other mechanical support devices including ECMO in the primary conservative group is allowed in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and 12 months.
Detailed Summary:
Sponsor: Na Homolce Hospital
Current Primary Outcome: Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- All-cause mortality [ Time Frame: 30 days ]
- All-cause mortality [ Time Frame: 6 months ]
- All-cause mortality [ Time Frame: 12 months ]
- Neurological outcome (according to Cerebral Performance Category scale) [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Na Homolce Hospital
Dates:
Date Received: November 23, 2014
Date Started: September 2014
Date Completion: September 2019
Last Updated: September 25, 2016
Last Verified: September 2016
