Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2

Status unconfirmed · Phase 2

Conditions studied: Critically Ill, Hyperglycemia

In brief

The Purpose of this study is to: 1. Introduce the refined, validated, and safe computerized bedside decision support tool for blood glucose management in critically ill adult and pediatric ICU patients that was studied in Phase 1 into a second group of naïve ICUs, none of which participated in eProtocol-insulin development, refinement or validation 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.

Key facts

Study ID

NCT00654797

Run by

Intermountain Health Care, Inc.

People needed

200

Starts

2007-09-01

Expected to finish

2018-12-01

Last updated by the study team

2015-02-26

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.

You may not qualify if…

• Pregnancy (negative pregnancy test required for females of child-bearing age)
• Age less than one month
• Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
• 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
• 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)
• Severe chronic liver disease (Child-Pugh score >10)

Where it is running

• Childrens Hospital Centeral California — Madera, California, United States (enrolling)
• Childrens Hospital of Minnesota - St. Paul — Saint Paul, Minnesota, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• Cornell University Medical College — New York, New York, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• University of Texas Medical Branch at Galveston — Galveston, Texas, United States (enrolling)
• Ben Taub General Hospital — Houston, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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