Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

The Ohio State University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: Detemir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00717288

60016576 (Other Identifier)

2007H0210

Details and patient eligibility

About

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).

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 3 patient groups

1

Active Comparator group

Description:

Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily

Treatment:

Drug: Detemir

Drug: Detemir

Drug: Detemir

2

Active Comparator group

Description:

Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily

Treatment:

Drug: Detemir

Drug: Detemir

Drug: Detemir

3

Active Comparator group

Description:

Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily

Treatment:

Drug: Detemir

Drug: Detemir

Drug: Detemir