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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Karolinska Institutet
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Plasma glucose levels
Study Overview
Brief Summary
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.
Detailed Description
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 of ulcer infection and/ or during 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.
The infusion starts when patients who met the eligibility criteria has signed the informed consent. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients are eligible for inclusion if the following criteria are fulfilled:
- •Patients with diabetes type 1 or type
- •Older than 18 years.
- •Patients scheduled for cardio- vascular surgery and/ or acute ulcer infection.
- •Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
- •Informed consent obtained.
Exclusion Criteria
- •Patients having any of the following at randomization will not be included in the study:
- •Unconsciousness: not possible to wake up.
- •Ketoacidosis: pH less or equal to 7.
- •Hyperosmolar syndrome: S-Na more or equal to 150 mmol/L.
- •Kidney failure: calculated GFR < 30 mL/min.
- •Pregnancy.
- •Mental condition making the subject unable to understand the concepts and risk of the study
Arms & Interventions
Insulin infusion (aspart)
Intervention: Insulin infusion (Procedure)
Standard care
Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.
Outcomes
Primary Outcomes
Plasma glucose levels
Time Frame: 4 weeks
Secondary Outcomes
- Hospital stay(4 weeks)
- HbA1c(4 weeks)
- laboratories for inflammation and oxidative stress(4 weeks)
Investigators
Mats Bonnier
MD
Karolinska Institutet