MedDataX Logo

Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

NCT ID: NCT00717288

Last Updated: 2011-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type ACTIVE_COMPARATOR

Detemir

Intervention Type DRUG

Detemir dosed at 50% of calculated basal insulin infusion requirements

2

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

Group Type ACTIVE_COMPARATOR

Detemir

Intervention Type DRUG

Detemir dosed at 65% of calculated basal insulin infusion requirements

3

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

Group Type ACTIVE_COMPARATOR

Detemir

Intervention Type DRUG

Detemir dosed at 80% of calculated basal insulin infusion requirements

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Detemir

Detemir dosed at 50% of calculated basal insulin infusion requirements

Intervention Type DRUG

Detemir

Detemir dosed at 65% of calculated basal insulin infusion requirements

Intervention Type DRUG

Detemir

Detemir dosed at 80% of calculated basal insulin infusion requirements

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Levemir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kathleen Dungan

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathleen M Dungan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

60016576

Identifier Type: OTHER

Identifier Source: secondary_id

2007H0210

Identifier Type: -

Identifier Source: org_study_id