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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779701
• Other study ID #: TU10526
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2008
• Last updated: May 22, 2015
• Start date: March 2007
• Est. completion date: October 2009

Study information

• Verified date: May 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Drug:
• Insulin
Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Achieve Glycemic Control	Mean time to glycemic control 225 minutes.	Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.	Yes