High-dose Insulin Euglycemic Therapy in Non-Toxic Acute Cardiogenic Shock.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Oslo Universitetssykehus HF
- Enrollment
- 20
- Locations
- 1
- 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).
Study Overview
Brief Summary
The main objective is to assess the efficacy and safety of HIET in non-toxic cardiogenic shock using invasive hemodynamic monitoring, Hence to investigate the hemodynamic effects and safety of the potentially new inotropic and cardiovascular stabilizing agent as treatment in NTCS.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients arriving at the study sites with NTCS will be screened. Inclusion criteria: Patients with primary NTCS meet SCAI classification C, D or E (i.e. classical cardiogenic shock). These features include systolic blood pressure < 90 mmHg for > 30 minutes with appropriate fluid resuscitation with clinical and laboratory evidence of end-organ damage.
Exclusion Criteria
- •Cardiac shock etiologies where etiologies where HIET is either established therapy or considered futile: Toxic cardiogenic shock by intoxication of beta-blockers or calcium channel blockers. Acute coronary syndrome. Myocarditis. Cardiac tamponade. Pulmonary embolism. Failure to establish PAC. Failure to provide informed consent. Participation in a different RCT. Known hypersensitivity to insulin lispro or any of the excipients.
Arms & Interventions
Humalog 100 units/ml solution for injection in vial
Intervention: Humalog 100 units/ml solution for injection in vial (Drug)
GLUCOSE 50 % AGUETTANT, solution pour perfusion
Intervention: GLUCOSE 50 % AGUETTANT, solution pour perfusion (Drug)
Potassium Chloride MONICO 2 mEq/mL - concentrate for solution for infusion, 10 ampoules 10 mL
Intervention: Potassium Chloride MONICO 2 mEq/mL - concentrate for solution for infusion, 10 ampoules 10 mL (Drug)
Outcomes
Primary Outcomes
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 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 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 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 - 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 - 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.
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 - 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 - Left ventricular ejection fraction assessed by echocardiography
Exploratory long-term endpoints at 6 weeks - Kidney function assessed by eGFR and plasma urea
Exploratory long-term endpoints at 6 weeks - Kidney function assessed by eGFR and plasma urea
Secondary Outcomes
No secondary outcomes reported
Investigators
Regional research support in Health South-East
Scientific
Oslo Universitetssykehus HF