High-dose Insulin Euglycemic Therapy in Non-Toxic Acute Cardiogenic Shock.

Condition studied

Non-toxic acute cardiogenic shock

Investigational medicinal product(s)

Every trial of Humalog across our registers →

Eligibility

Primary endpoint

Primary exploratory efficacy endpoints at 48 hours - Changes from baseline to 48 hours in the following hemodynamic parameters using continuous pulmonary artery catheterization with thermodilution and blood sampling: cardiac output, pulmonary vascular resistance, svO2, P (v-a) CO2, lactate and N-terminal pro-B-type natriuretic peptide (NT-proBNP)., Primary exploratory efficacy endpoints at 48 hours - Changes from baseline to 48 hours in the following echocardiographic parameters: Left ventricular ejection fraction, left ventricular outflow tract velocity time integral (LVOT VTI) and E/e’., Primary exploratory efficacy endpoints at 48 hours - Changes from baseline in kidney function assessed by plasma creatinine-based estimated glomerular filtration rate (eGFR), plasma urea and urine output., Primary exploratory efficacy endpoints at 48 hours - Changes from baseline in heartrate, mean arterial blood pressure and Sequential Organ Failure Assessment (SOFA) score., Primary exploratory efficacy endpoints at 48 hours - Incident hemodynamically compromising arrhythmias assessed by continuous ECG-monitoring., Primary exploratory efficacy endpoints at 48 hours - Total dose of vasoactive drugs, inotropic drugs and diuretics., Exploratory long-term endpoints at 6 weeks - Survival free of mechanical circulatory support, Exploratory long-term endpoints at 6 weeks - Left ventricular ejection fraction assessed by echocardiography, Exploratory long-term endpoints at 6 weeks - Kidney function assessed by eGFR and plasma urea