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

This study is currently recruiting participants.

Verified by Temple University, October 2008

First Received: October 22, 2008 Last Updated: October 23, 2008 History of Changes

Sponsored by:	Temple University
Information provided by:	Temple University
ClinicalTrials.gov Identifier:	NCT00779701

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 IV

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

Resource links provided by NLM:

Drug Information available for: Insulin

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

Contacts

Contact: Hannah Reimer, BSN

215-707-5483

hreimer@temple.edu

Locations

United States, Pennsylvania
Temple University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 191440
Contact: Hannah Reimer, BSN 215-707-5483 hreimer@temple.edu
Principal Investigator: Nina T Gentile, MD

Sponsors and Collaborators

Temple University

More Information

No publications provided

Responsible Party:	Temple University ( Nina T. Gentile, MD )
Study ID Numbers:	TU10526
Study First Received:	October 22, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779701 History of Changes
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)

Study placed in the following topic categories:

Hypoglycemic Agents
Critical Illness
Benzocaine
Emergencies
Insulin

Additional relevant MeSH terms:

Disease Attributes
Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs

Emergencies
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 01, 2009