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Sponsored by: |
United States Army Institute of Surgical Research |
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Information provided by: | United States Army Institute of Surgical Research |
ClinicalTrials.gov Identifier: | NCT00589589 |
This study is intended to fill the knowledge gap regarding the burn population with research that achieves scientific merit. we will determine the effectiveness of the computer decision support system (CDSS) to facilitate glucose management in the critically ill burn patient.
The EndoTool™ computer decision support system will achieve glycemic control (defined as 80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).
Condition | Intervention | Phase |
---|---|---|
Burns Hypoglycemia |
Device: Endo Tool |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Computer Decision Support to Achieve Glycemic Control in the ICU |
Estimated Enrollment: | 24 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Device: Endo Tool
Computer tool to help achieve glucose control
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This is a prospective, paired, randomized, cross-over design, with two groups: current standard of care using the USAISR Burn Center insulin titration nomogram (Appendix A) and insulin management using EndoTool™ (MD Scientific, LLC) decision support software. Patients will thus serve as their own controls.
Upon admission to the burn ICU, patients expected to require continuous insulin infusion for a minimum of 7 days will be placed on EndoTool™ CDSS for the first 24 hours of glycemic management. At the 24 hour mark the patients will be randomly assigned to either the CDSS or standard of care group in pairs.
Thus, the first subject will be randomized to a group and the second subject will be placed in the alternate group. This method will ensure equal numbers of patients are enrolled in each group to eliminate bias of timing of intervention due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elizabeth A. Mann, RN, MSN | 210-916-7153 | elizabeth.amm@amedd.army.mil |
Contact: Annette R McClinton, RN,MA | 210-916-2834 | annette.mcclinton@amedd.army.mil |
United States, Texas | |
US Army Institute of Surgical Research | Recruiting |
Fort Sam Houston, Texas, United States, 78234 | |
Contact: Annette R. McClinton, RN, MA 210-916-2834 annette.mcclinton@amedd.army.mil | |
Contact: Lynn Platteborze, BS, MS 210-916-9351 lynn.platteborze@amedd.army.mil | |
Principal Investigator: Elizabeth A Mann, RN, MSN |
Principal Investigator: | Elizabeth A Mann, RN, MSN | United States Army Institute of Surgical Research |
Responsible Party: | USAISR ( Major Elizabeth Mann, AN ) |
Study ID Numbers: | H-07-040 |
Study First Received: | December 24, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00589589 History of Changes |
Health Authority: | United States: Federal Government |
burns hypoglycemia hyperglycemia glucose monitoring |
Burns Metabolic Diseases Hyperglycemia |
Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder |
Metabolic Diseases Glucose Metabolism Disorders Hypoglycemia |