Clinical trial NCT00700154: Insulin Infusion Diabetes Ulcer
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Insulin Resistance
Hyperglycemia
Surgery
Ulcers
Infection
Keywords: Vascular Surgery
Complications
Hyperglycemia
Insulin infusion
Diabetic ulcers
Infection
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

This is a randomized prospective, open controlled trial of target controlled insulin infusion vs conventional antidiabetic therapy in diabetic patients. Diabetics planned treated for ulcer infection and/ or after elective cardio- vascular surgery, who met inclusion, not exclusion criteria and choose to participate will be included and randomized.

Duration of study:

The infusion starts when patients who met the eligibility criteria have signed the informed consent and for the surgery group 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.

Selection of patients:

Patients with diabetic ulcer infection and/or planned cardio-vascular intervention will be enrolled.

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):

The insulin infusion starts when the patients full fill the eligibility criteria, has signed the informed consent and for the surgery group prior the start of the operation. It controls by regular capillary plasma glucose tests and continues for three 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.

Eligibility criteria: Inclusion Criteria:

* Patients are eligible for inclusion if the following criteria are fulfilled:

  * Patients with diabetes type 1 or type 2.
  * 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 7.30.
  * 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

Primary outcomes:
measure: Plasma glucose levels
timeFrame: 4 weeks
Secondary outcomes:
measure: Hospital stay
timeFrame: 4 weeks
measure: HbA1c
timeFrame: 4 weeks
measure: laboratories for inflammation and oxidative stress
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Vascular Surgery, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kerstin Brismar, Professor
role: STUDY_DIRECTOR
affiliation: Karolinska Institutet
name: Mats Bonnier, M.D
role: PRINCIPAL_INVESTIGATOR
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