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Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508024-36-00
Enrollment
46
Registered
2024-03-11
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

Brief summary

• Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first

Detailed description

Change in pulse pressure from baseline to 72h after initiation of ECMO or before cessation of ECMO support, whichever occurs first; ECMO weaning failure, defined as death during ECMO support, death within 24 h after ECMO removal or need for reimplantation of ECMO within 24 h. All cause mortality at 28 days, Urinary output for the first 48 hours post cessation of ECMO support, Central venous saturation at 4, 8, 12, 24 and 48 hours post cessation of ECMO support, Total days requiring ECMO

Interventions

DRUGPulver zur Herstellung einer Injektions- oder einer Infusionslösung
DRUGLevosimendan EQL Pharma 2
DRUG5mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken, Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first

Secondary

MeasureTime frame
Change in pulse pressure from baseline to 72h after initiation of ECMO or before cessation of ECMO support, whichever occurs first; ECMO weaning failure, defined as death during ECMO support, death within 24 h after ECMO removal or need for reimplantation of ECMO within 24 h. All cause mortality at 28 days, Urinary output for the first 48 hours post cessation of ECMO support, Central venous saturation at 4, 8, 12, 24 and 48 hours post cessation of ECMO support, Total days requiring ECMO

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026