Cardiogenic Shock
Conditions
Brief summary
Systolic blood pressure (SBP) area under the curve (AUC) from start of infusion to 6 hours.
Detailed description
Vasoactive-Inotropic Score (VIS) at 24 and 48 hours post baseline. VIS is calculated as doses of dopamine + dobutamine + 100×epinephrine + 50×levosimendan + 10×milrinone + 100×vasopressin + 100×norepinephrine (µg/kg/min), using the dosing rates of vasoactive and inotropic medications., Days alive and out of the hospital through Day 30 from randomization., Time to treatment failure defined by need for initiation of new inotropes or increase in dose of inotropes or mechanical support (circulatory, respiratory, or renal) or death through Day 5 from randomization.
Interventions
DRUGIstaroxime
DRUGLActose
Sponsors
Windtree Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic blood pressure (SBP) area under the curve (AUC) from start of infusion to 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vasoactive-Inotropic Score (VIS) at 24 and 48 hours post baseline. VIS is calculated as doses of dopamine + dobutamine + 100×epinephrine + 50×levosimendan + 10×milrinone + 100×vasopressin + 100×norepinephrine (µg/kg/min), using the dosing rates of vasoactive and inotropic medications., Days alive and out of the hospital through Day 30 from randomization., Time to treatment failure defined by need for initiation of new inotropes or increase in dose of inotropes or mechanical support (circulatory, respiratory, or renal) or death through Day 5 from randomization. | — |
Countries
Czechia, Italy, Poland
Outcome results
None listed