CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 122 enrolled
Drug / intervention
Veno-arterial extracorporeal membrane oxygenation (ECMO) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02301819
NCT02301819N/ACompleted

ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock

Na Homolce Hospital·interventional·Posted Nov 26, 2014·Updated Apr 5, 2023

In Brief

A clinical study evaluating Veno-arterial extracorporeal membrane oxygenation (ECMO) and Early conservative therapy according to standard practice for Cardiogenic Shock. Completed, enrolled 122 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 26, 2014
Enrollment StartSep 1, 2014
Primary CompletionAug 1, 2022
Study CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 11.6 years ago

Interventions

Veno-arterial extracorporeal membrane oxygenation (ECMO)device

Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.

Early conservative therapy according to standard practiceother

Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.