NCT02301819

ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Na Homolce Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	Veno-arterial extracorporeal membrane oxygenation (ECMO)	Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.
OTHER	Early conservative therapy according to standard practice	Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.

Timeline

• Start date: 2014-09-01
• Primary completion: 2022-08-01
• Completion: 2023-01-01
• First posted: 2014-11-26
• Last updated: 2023-04-05

Locations

4 sites across 1 country: Czechia