Expired Study
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Columbus, Ohio 43210


Purpose:

In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).


Study summary:

High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.


Criteria:

Inclusion Criteria: - diabetes mellitus - post-cardiothoracic surgery - requiring an insulin infusion of at least 1 unit/hour - Age 18-75 Exclusion Criteria: - Glucocorticoids - TPN or tube feeds - Pregnancy - Surgical procedures in the next 48 hours for whom IV insulin will be expected - Expected length of stay less than 48 hours following cessation of the insulin drip - Patients using subcutaneous insulin pumps - Diabetic ketoacidosis - End-stage renal disease - End-stage liver disease - Coma - Potentially sensitive admissions: prisoners, HIV, suicidality - Unable to give consent in English


NCT ID:

NCT00717288


Primary Contact:

Principal Investigator
Kathleen M Dungan, MD
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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