Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1

Hyperglycemia Clinical Trial

Official title:

Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric ICU Patients:Further Refinement and Validation of eProtocol-insulin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00655460
• Other study ID #: N01-HC-45210-1
• Secondary ID: HHSN268200425210
• Status: Recruiting
• Phase: Phase 2
• First received: April 7, 2008
• Last updated: February 24, 2015
• Start date: February 2006
• Est. completion date: December 2018

Study information

• Verified date: January 2008
• Source: Intermountain Health Care, Inc.
• Contact: Alan H Morris, MD
• Phone: 801-408-1610
• Email: Alan.Morris[@]intermountainmail.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The Purpose of this study is to:

1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.

2. Monitor how often low blood sugar levels occur during use of the bedside tool.

3. Determine how the computerized tool effects the workload of the ICU nurses.

Description:

This first phase will be a prospective cohort study. We will validate the bedside tool in at least 4 adult and at least 4 pediatric ICUs and if necessary we will modify the bedside tool. The computerized bedside tool will be considered refined if >90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month and older

Eligibility

Inclusion Criteria:

1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for glucose control in their ICUs would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine >3 mg/kg/min, dobutamine, epinephrine, or vasopressin).

2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose control in participating adult ICUs include critically ill patients with an anticipated ICU length of stay of 3 or more days.

Exclusion Criteria:

1. Pregnancy (negative pregnancy test required for females of child-bearing age)

2. Age less than one month

3. Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis

4. Acute or chronic liver disease with any documented episode of blood or plasma glucose <60 mg/dl within the 24 hours prior to study entry

5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care)

6. Severe chronic liver disease (Child-Pugh score >10)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hyperglycemia

Intervention

Procedure:
• glucose control with computer generated recommendations
Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Pennsylvania State Children's Hospital	Hersey	Pennsylvania
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	LDS Hospital	Salt Lake City	Utah
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Wake Forest Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable during Phase I will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions: more than 90 % of all instructions accepted by the bedside clinician).		3 years	Yes
Secondary	Proportion of glucose determinations within the range of 70-110 mg/dl (3.9-6.1 mMol/l)		3 years	Yes
Secondary	Nursing perception of workload in comparison to ordinary care		3 years	No