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Completed

NCT Number: NCT00717288

Transitioning Open Heart Surgery Patients From Insulin Infusions to 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).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Detemir

Drug

Detemir dosed at 50% of calculated basal insulin infusion requirements

Other names: Levemir

Primary outcomes

  1. 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

  1. Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)

    Time frame: 48 hours

    Number of patients with hypoglycemia (defined as glucose <65 mg/dl)

  2. Reversion to Intravenous Insulin for Failure of Glycemic Control

    Time frame: 72 hours

    Number of participants who went back on intravenous insulin for failure of glycemic control.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2008
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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