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

This study has been completed.
Information provided by (Responsible Party):
Nina T Gentile, Temple University Identifier:
First received: October 22, 2008
Last updated: May 22, 2015
Last verified: May 2015
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 Intervention Phase
Drug: Insulin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation

Resource links provided by NLM:

Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Mean time to glycemic control 225 minutes.

Enrollment: 27
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All subjects placed on insulin infusion.
Drug: Insulin
Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Nina T Gentile, MD, Temple University Identifier: NCT00779701     History of Changes
Other Study ID Numbers: TU10526 
Study First Received: October 22, 2008
Results First Received: May 22, 2015
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board

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 processed this record on December 07, 2016