Clinical trial NCT00717288: Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir
Official title: Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: diabetes
hyperglycemia
open heart surgery
cardiothoracic surgery
detemir
insulin infusion
intravenous insulin
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2008-07-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Coma
* Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
* Unable to give consent in English

Primary outcomes:
measure: Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
timeFrame: day 2, day 3
Secondary outcomes:
measure: Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
timeFrame: 48 hours
measure: Reversion to Intravenous Insulin for Failure of Glycemic Control
timeFrame: 72 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kathleen M Dungan, MD
role: PRINCIPAL_INVESTIGATOR
References: