Insulin Infusion Diabetes Ulcer (IINDU)

December 21, 2020 updated by: Mats Bonnier, Karolinska Institutet

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-171 76
        • Department of Vascular Surgery, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose levels
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 4 weeks
4 weeks
Hospital stay
Time Frame: 4 weeks
4 weeks
laboratories for inflammation and oxidative stress
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Mats Bonnier, M.D, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

December 21, 2020

Study Completion (ACTUAL)

December 21, 2020

Study Registration Dates

First Submitted

June 9, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (ESTIMATE)

June 18, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IICVS_00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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