Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00779701
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : June 9, 2015
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
Temple University

Brief Summary:
Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.

Condition or disease Intervention/treatment Phase
Hyperglycemia Drug: Insulin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Arm Intervention/treatment
All subjects placed on insulin infusion.
Drug: Insulin
Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL

Primary Outcome Measures :
  1. Time to Achieve Glycemic Control [ Time Frame: Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with blood glucose ≥130 mg% considered to be critically ill as defined by:

APACHE II score ≥9 (See Appendix 1) OR >2 SIRS criteria with lactate ≥ 4 or BP < 90mmHg despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)

Exclusion Criteria:

  • Patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ED.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00779701

United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 191440
Sponsors and Collaborators
Temple University
Principal Investigator: Nina T Gentile, MD Temple University

Responsible Party: Temple University Identifier: NCT00779701     History of Changes
Other Study ID Numbers: TU10526
First Posted: October 24, 2008    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: March 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Temple University:
Glycemic control

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs