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

Phase 1

Recruiting

• Conditions: Cardiogenic Shock; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508024-36-00
• Lead Sponsor: Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

•Age = 18 years; •Undergoing ECMO for cardiogenic shock or refractory cardiac arrest

Exclusion Criteria

•Coma with fixed dilatation of pupils that was not induced by drugs or other circumstances indicating likely futility •Mechanical cause of cardiogenic shock (e.g., ventricular septal defect or papillary muscle rupture) •Onset of shock more than 12 hours before screening •Massive pulmonary embolism •Severe peripheral arterial disease precluding insertion of ECMO cannula •Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation) •Age > 90 years •Severe concomitant disease associated with a life expectancy of less than 6 months •Pregnant women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified