Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Temple University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00779701
First received: October 22, 2008
Last updated: January 12, 2010
Last verified: September 2009
History of Changes
  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
Glycemic Control
 Drug: Regular 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 170
Study Start Date: March 2007
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
All subjects placed on insulin infusion.
 Drug: Regular Insulin
Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779701

Locations
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 191440
Sponsors and Collaborators
Temple University
  More Information

No publications provided

Responsible Party: Nina T. Gentile, MD, Temple University
ClinicalTrials.gov Identifier: NCT00779701     History of Changes
Other Study ID Numbers: TU10526
Study First Received: October 22, 2008
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
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)

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Insulin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013