Back to resultsStrict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Hyperglycemia, Glycemic control
Eligibility 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.
Sites / Locations
- Temple University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
All subjects placed on insulin infusion.
Outcomes
Primary Outcome Measures
Time to Achieve Glycemic Control
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00779701
Brief Title
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Official Title
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Hyperglycemia, Glycemic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
All subjects placed on insulin infusion.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin infusion titrated to patients blood glucose to maintain blood glucose between 80-110mg/dL
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina T Gentile, MD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191440
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
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