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OpenTrials
Completed

NCT Number: NCT00779701

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 191440, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2008
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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