Clinical trial NCT00589589: Computer Decision Support to Achieve Glycemic Control in the ICU
Official title: Computer Decision Support to Achieve Glycemic Control in the ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burns
Hypoglycemia
Keywords: burns
hypoglycemia
hyperglycemia
glucose monitoring
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2008-01-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 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intervention due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* military or civilian burns on continuous insulin infusion for 7 days

Exclusion Criteria:

* not expected to receive insulin for 7 days
* less than 18 years old
* enrolled in the Continuous Glucose monitoring Study

Primary outcomes:
measure: Time spent in target glucose range of 80-110 mg/dL.
timeFrame: 48 hours
Secondary outcomes:
measure: Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL.
timeFrame: 7 days
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Elizabeth A Mann, RN, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P. Outcome benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control. Crit Care Med. 2003 Feb;31(2):359-66. doi: 10.1097/01.CCM.0000045568.12881.10.