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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523858-13-01
Enrollment
20
Registered
2026-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-toxic acute cardiogenic shock

Brief summary

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

Interventions

DRUGPotassium Chloride MONICO 2 mEq/mL - concentrate for solution for infusion
DRUG10 ampoules 10 mL
DRUGGLUCOSE 50 % AGUETTANT
DRUGsolution pour perfusion

Sponsors

Oslo Universitetssykehus HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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 effi

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 2, 2026