CTIS2023-508024-36-00RecruitingPhase 1
Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trial
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken0 sites46 target enrollmentStarted: November 2, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 46
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
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
Investigators
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