Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
Overview
- Phase
- Phase 4
- Intervention
- Detemir
- Conditions
- Diabetes Mellitus
- Sponsor
- Ohio State University
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Kathleen Dungan
Assistant Professor of Medicine
Ohio State University
Eligibility Criteria
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
- •Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
Arms & Interventions
1
Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily
Intervention: Detemir
2
Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily
Intervention: Detemir
3
Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Intervention: Detemir
Outcomes
Primary Outcomes
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
Time Frame: day 2, day 3
Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3
Secondary Outcomes
- Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)(48 hours)
- Reversion to Intravenous Insulin for Failure of Glycemic Control(72 hours)