Recruiting
Phase 2

Blood Glucose Control

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT00655460

Conditions

Critically Ill

Hyperglycemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

glucose control with computer generated recommendations

Study Details

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 low blood sugar levels occur during use of the bedside tool.
3. Determine how the computerized tool effects the workload of the ICU nurses.

Conditions

Critically Ill

Hyperglycemia

Study ID

NCT00655460

Start date

Feb, 2006

Status verified date

Jan, 2008

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: eProtocol

Interventions

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.

Primary outcome measure

  • 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). [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Alan H Morris, MD

801-408-1610Alan.Morris@intermountainmail.org

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Principal Investigator:

Roy Brower, MD

Wake Forest Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

Robert D Hite, MD

LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

Principal Investigator:

James Orme, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Feb 26, 2015

Last verified

Jan, 2008

Keywords

  • Glucose
  • Insulin
  • computer
  • critical care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2015-02-26.