Subcutaneous insulin therapy of hyperglycemia after initiation of oral intake in the IC

Active, not recruiting

• Conditions: Hyperglycemia is very common in hospitalized, critically ill patients and is associated with higher mortality and morbidity. Careful monitoring and therapy of hyperglycemia have become standard in the ICU. Therapy of hyperglycemia by subcutaneously applied insulin after initiation of oral intake in the ICU is going to be investigated.; MedDRA version: 9.1Level: LLTClassification code 10042216Term: Stress induced hyperglycemia

• Registration Number: EUCTR2007-002773-30-AT
• Lead Sponsor: Herz-, Thorax- und Gefäßchirurgische Anästhesie und Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients between 18 and 90 years old, admitted to our ICU and requiring treatment with insulin (fasting blood glucose > 125 mg/dl) after initiation of oral intake in the ICU.
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

Patients
-being pregnant at ICU-admission
-with Glasgow-Coma-Scale < 12
- having had a lung- or hearttransplantation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Comparison of occurrence of hypoglycemia (blood glucose < 40 mg/dl).<br>nursing work load and nursing satisfaction.;Main Objective: To determine whether subcutaneous Insulin therapy, consisting of prandial Insulin (NovoRapid, Novo Nordisk) and basis insulin (Levemir, Novo Nordisk) leads to a better control of hyperglycemia with less variability of blood glucose concentration in ciritcally ill patients in the ICU after initiation of oral intake compared to continuous infusion of Insulin (NovoRapid, Novo Nordisk).;Primary end point(s): Comparison of glycemic control between the two patientgroups, of which one received subcutaneously applied Insulin (prandial insulin and basis insulin) and the other received intravenously applied insulininfusion. 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.