Insulin Infusion Diabetes Ulcer (IINDU)
Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular surgery.
- The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during ulcer infection and after cardio- vascular surgery.
- Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.
Procedure: Insulin infusion
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Insulin Infusion on Metabolic Control and Inflammation in Diabetic Patients During Cardio-vascular Intervention and/or Treatment for Acute Foot Ulcer Infection.|
- Plasma glucose levels [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Hospital stay [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- HbA1c [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- laboratories for inflammation and oxidative stress [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Insulin infusion (aspart)||
Procedure: Insulin infusion
The infusion, a fast acting insulin analog 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 three 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.
Other Name: Insulin aspart: NovoRapid
No Intervention: Standard care
Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.
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|Department of Vascular Surgery, Karolinska University Hospital|
|Stockholm, Sweden, SE-171 76|
|Study Director:||Kerstin Brismar, Professor||Karolinska Institutet|
|Principal Investigator:||Mats Bonnier, M.D||Karolinska Institutet|