Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Detemir
* Drug: Detemir
* Drug: Detemir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetes mellitus post-cardiothoracic surgery requiring an insulin infusion of at least 1 unit/hour Age 18-75 Exclusion Criteria: Glucocorticoids total parenteral nutrition (TPN) or tube feeds Pregnancy Surgical procedures in the next 48 hours for whom intravenous (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, human immunodeficiency virus(HIV), suicidality Unable to give consent in English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily | Drug: Detemir<br>* Detemir dosed at 50% of calculated basal insulin infusion requirements<br>* Other names: Levemir;|
| Active Comparator: 2<br>Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily | Drug: Detemir<br>* Detemir dosed at 65% of calculated basal insulin infusion requirements<br>|
| Active Comparator: 3<br>Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily | Drug: Detemir<br>* Detemir dosed at 80% of calculated basal insulin infusion requirements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 | Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3 | day 2, day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) | Number of patients with hypoglycemia (defined as glucose <65 mg/dl) | 48 hours | 
| Reversion to Intravenous Insulin for Failure of Glycemic Control | Number of participants who went back on intravenous insulin for failure of glycemic control. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, hyperglycemia, open heart surgery, cardiothoracic surgery, detemir, insulin infusion, intravenous insulin