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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00779701
First Posted: October 24, 2008
Last Update Posted: March 16, 2017
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.
Information provided by (Responsible Party):
Temple University
  Purpose
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
Hyperglycemia Drug: Insulin Phase 4

Study Type: Interventional
Study Design: 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

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. ]

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

  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00779701


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

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00779701     History of Changes
Other Study ID Numbers: TU10526
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: May 22, 2015
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:
Hyperglycemia
Glycemic control

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