LEVOSIMENDAN for Cardiogenic shock

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Undergoing ECMO for cardiogenic shock or refractory cardiac arrest"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- \tChange 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","definition_or_measurement_approach":"Measured by Doppler echocardiography: change in left ventricular outflow tract velocity time integral from baseline to 72 hours after ECMO initiation or before cessation of ECMO support, whichever occurs first."}

Secondary endpoints

• {"endpoint_text":"- Change in pulse pressure from baseline to 72h after initiation of ECMO or before cessation of ECMO support, whichever occurs first\n- 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.\n- All cause mortality at 28 days\n- Urinary output for the first 48 hours post cessation of ECMO support\n- Central venous saturation at 4, 8, 12, 24 and 48 hours post cessation of ECMO support\n- Total days requiring ECMO","definition_or_measurement_approach":"Change in pulse pressure: from baseline to 72h after ECMO initiation or before cessation. ECMO weaning failure: defined as death during ECMO support, death within 24 h after ECMO removal or need for reimplantation within 24 h. All-cause mortality assessed at 28 days. Urinary output measured for first 48 hours post cessation. Central venous saturation measured at specified timepoints (4,8,12,24,48 hours). Total days requiring ECMO recorded as days."}

Austria

Earliest CTIS Part Ii Submission Date

29-02-2024

Latest Decision Or Authorization Date

11-03-2024

Processing Time Days

11

Number Of Sites

1

Number Of Participants

46

Primary sponsor

Full Name

Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Austria

Co-sponsors

• Medical University Of Vienna