Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
2	Detemir	Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
1	Detemir	Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
3	Detemir	Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily

Primary Outcome Measures

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

Secondary Outcome Measures

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