Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Detemir; Drug: Detemir; Drug: Detemir

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: July 15, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: August 30, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: diabetes; hyperglycemia; insulin infusion; cardiothoracic surgery; open heart surgery; detemir; intravenous insulin
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Detemir
• Other Study ID Numbers: 2007H0210; 60016576 (Other Identifier: Other)