Therapy of hyperglycemia by intravenously applied insulin is going to be investigated. Hyperglycemia is very common in hospitalized, critically ill patients, even if they have not previously had diabetes. Studies have established that in-hospital hyperglycemia is associated with higher mortality and morbidity. Therefore, careful monitoring and therapy of hyperglycemia have become standard in the ICU and include treatment with continuous infusion of insulin. MedDRA version: 9.1 Level: LLT Clas
Conditions
Interventions
Trade Name: NovoRapid®,
Product Name: NovoRapid
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094236
Other descriptive name: NovoRapid
Concentration uni
Sponsors
Herz-, Thorax- und Gefäßchirurgische Anästhesie und Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between 18 and 90 years old ·admitted to the ICU and requiring treatment with infusion of insulin within 4 hours after ICU admission (blood glucose concentration exceeding 125 mg/dL) OR ·admitted to the ICU, already receiving treatment with continuous infusion of insulin at admission. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients ·being pregnant at ICU-admission ·having a shock with serum lactate > 8 mmol/l at ICU-admission ·with severe hypoxia (SpO215 min. at ICU-admission) ·having an aortic aneurysm and a hypothermic cardiopulmonary arrest during the operation >60 min. ·having had a lung- or hearttransplantation •who were not admitted within 24 hours after the surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether continuous infusion of Insulinaspart ( NovoRapidÒ, Novo Nordisk) leads to a better control of glycemia with less variability of blood glucose concentration in critically ill patients in the ICU compared to continuous infusion of human insulin (ActrapidÒ, Novo Nordisk). ;Secondary Objective: Comparison of occurrence of hypoglycemia (blood glucose <40 mg/dL);Primary end point(s): Comparison of glycemic control in the two patientgroups, of which one is receiving continuous infusion of Insulinaspart (NovoRapidÒ, Novo Nordisk) and the other is receiving continuous infusion of human insulin (ActrapidÒ, Novo Nordisk). The AUC (area under the curve) of glucose concentrations outside of target concentration from 100 to 125 mg/dl will be compared between these two groups in 4 measurement periods (0 to 6 hours after admission, 6 to 12 hours after admission, 12 to 24 hours after admission and 24 to 48 hours after admission). | — |
Countries
Austria
Outcome results
None listed