Primary Outcome Measures:
- Plasma glucose levels. HbA1c levels [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Intervention Details:
Procedure: Insulin infusion
The infusion, a fast acting insulin analog (lispro/ aspart/ glulisin) in 1 Unit/ml of NaCl, starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for tree full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Procedure: Standard care
Glucose control according to standard care at the ward, ie sliding scale insulin at the discretion of responsible physician.
Introduction:
Normoglycemia is important for the outcome of acute surgical and medical conditions. Different insulin infusions have been studied to achieve normoglycemia and have proved to be useful. Insulin given by subcutaneous injections has duration between 3- 36 hours depending on the insulin brand and injection site compared to 10 minutes for intravenous given insulin. Different insulin infusions have been studied to achieve normoglycemia but the biological and chemical effects of insulin infusions have not been studied in routine operative care of patients with diabetes. Therefore, we aim to investigate the importance of normoglycemia for the optimal treatment in routine cardio- vascular surgery care among diabetics.
Hypothesis:
Target controlled insulin infusion is more effective in reducing hyperglycemia, improve healing of inflammation and infection in diabetics compared to conventional antidiabetic therapy.
Study Design:
This is a randomized prospective, open controlled trial of target controlled insulin infusion vs conventional antidiabetic therapy in diabetic patients. Diabetics planned for elective cardio- vascular surgery, who met inclusion and not exclusion criteria and choose to participate will be included and randomized.
Duration of study:
The infusion starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for tree full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Selection of patients:
Patients planned for elective cardio- vascular surgery will be enrolled. At least 90 patients will be included during a 24 month-enrollment period.
Treatment:
Eligible patients will be randomized to insulin infusion (group 1) for 3 days or therapy according to clinical practise (group 2).
Group 1 (intervention group):
Prior the start of the surgery the insulin infusion starts, controls by regular capillary plasma glucose tests and continues for tree days. The infusion stop on the fourth day, the insulin demand is estimated from the last 24 infusion hours by a specific algorithm and divided to 2-4 equal mealtime doses of mixinsulin. The first mealtime dose is given to the breakfast on the fourth day and the infusion continues for another 2 hours where after it is stopped. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
All patients will have a stop visit at the study end.
Patient assignment to treatment group:
Patients recruited in the clinic and hospital wards and meeting the criteria will be randomized.
Purpose
