Recruiting
Phase 2

Blood Glucose Management

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT00654797

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. 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.

Conditions

Critically Ill

Hyperglycemia

Study ID

NCT00654797

Start date

Sep, 2007

Status verified date

Feb, 2015

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 for feasibility during Phase-2 will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions). Proportion of glucose values < 40 mg/dl. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Alan Morris, MD

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

Locations

Childrens Hospital Centeral California

Recruiting

Madera, California, United States

Principal Investigator:

Ana Graciano, MD

Childrens Hospital of Minnesota - St. Paul

Recruiting

St. Paul, Minnesota, United States

Principal Investigator:

Stephen Kurachek, MD

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States

Principal Investigator:

Dan Levin, MD

Cornell University Medical College

Recruiting

New York, New York, United States

Principal Investigator:

Bruce Greenwald, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States

Principal Investigator:

Michelle Gong, MD

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States

Principal Investigator:

David Bowton, MD

Ohio State University

Recruiting

Columbus, Ohio, United States

Principal Investigator:

Ali Naeem, MD

University of Texas Medical Branch at Galveston

Recruiting

Galveston, Texas, United States

Principal Investigator:

Victor Cardenas, MD

Ben Taub General Hospital

Recruiting

Houston, Texas, United States

Principal Investigator:

Kalpalatha Guntupalli, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States

Principal Investigator:

Joseph Nates, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Feb 26, 2015

Last verified

Feb, 2015

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.