Computer Decision Support to Achieve Glycemic Control in the ICU

NCT ID: NCT00589589

Last Updated: 2015-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-01-31

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due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Conditions

Burns; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

Endo Tool

Intervention Type: DEVICE

Computer tool to help achieve glucose control

Interventions

Endo Tool

Computer tool to help achieve glucose control

Intervention Type: DEVICE

Other Intervention Names

Computer Software for glucose control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Responsible Party

Elizabeth Mann

Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth A Mann, RN, MSN

Role: PRINCIPAL_INVESTIGATOR

United States Army Institute of Surgical Research

Locations

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12576937 (View on PubMed)

Other Identifiers

H-07-040

Identifier Type: -

Identifier Source: org_study_id