Status:

UNKNOWN

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

Lead Sponsor:

Intermountain Health Care, Inc.

Conditions:

Critically Ill

Hyperglycemia

Eligibility:

All Genders

1+ years

Phase:

PHASE2

Brief 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 ...

Detailed 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 computeri...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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)

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2018

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00655460

Start Date

February 1 2006

End Date

December 1 2018

Last Update

February 26 2015

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Yale University

New Haven, Connecticut, United States, 05520

2

Johns Hopkins University

Baltimore, Maryland, United States, 21205

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

4

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

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