Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2 - Full Text View

Sponsored by:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00654797

Purpose

The Purpose of this study is to:

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

Condition	Intervention	Phase
Critically Ill Hyperglycemia	Procedure: glucose control with computer generated recommendations	Phase II

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-Insulin) in Adult And Pediatric Intensive Care Unit Patients-Second Phase (Phase-2): Distribution and Implementation of Validated eProtocol-Insulin in Naïve ICUs

Further study details as provided by National Center for Research Resources (NCRR):

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Time to reach the 80-110 mg/dl target [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Nursing perception of workload in comparison to ordinary care (efficacy and feasibility) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Proportion of glucose values 41-60 mg/dl [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
eProtocol: Experimental	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.

Detailed Description:

In the current second phase of this project (Phase-2), we will introduce the refined, validated, and safe eProtocol-insulin into a second group of naïve ICUs, none of which participated in eProtocol-insulin development, refinement or validation. Our primary goal in this second phase is to determine the feasibility of exporting this tool to naïve ICU environments. In this second phase we will also compare the effects of the eProtocol-insulin and ordinary care approaches to glucose control on the bedside nurse's experience.

This second phase will be a prospective cohort study. We will determine the feasibility of distributing eProtocol-insulin and will further validate eProtocol-insulin in >4 adult and >4 pediatric ICUs. If necessary we will modify eProtocol-insulin with an iterative refinement process, with Institutional Review Board (IRB) and independent Data and Safety Monitoring Board (DSMB) oversight. eProtocol-insulin will be considered refined if >90% of the instructions are accepted and if the percent of glucose values between 70 and 110 mg/dl (3.9-6.1 mMol/L) are equivalent to our Phase-1 refinement and validation experience of 46%%, and if the rate of glucose values < 40 mg/dl (2.2 mMol/l) is less than 0.5% of glucose measurements.

Eligibility

Ages Eligible for Study:	1 Month and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654797

Contacts

Contact: Alan Morris, MD

801-408-1610

Alan.Morris@intermountainmail.org

Locations

United States, California
Childrens Hospital Centeral California	Recruiting
Madera, California, United States
Principal Investigator: Ana Graciano, MD
United States, Minnesota
Childrens Hospital of Minnesota - St. Paul	Recruiting
St. Paul, Minnesota, United States
Principal Investigator: Stephen Kurachek, MD
United States, New Hampshire
Dartmouth Hitchcock Medical Center	Recruiting
Lebanon, New Hampshire, United States
Principal Investigator: Dan Levin, MD
United States, New York
Mount Sinai Hospital	Recruiting
New York, New York, United States
Principal Investigator: Michelle Gong, MD
Cornell University Medical College	Recruiting
New York, New York, United States
Principal Investigator: Bruce Greenwald, MD
United States, North Carolina
Wake Forest University Baptist Medical Center	Recruiting
Winston-Salem, North Carolina, United States
Principal Investigator: David Bowton, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States
Principal Investigator: Ali Naeem, MD
United States, Texas
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
University of Texas Medical Branch at Galveston	Recruiting
Galveston, Texas, United States
Principal Investigator: Victor Cardenas, MD

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Alan H Morris, MD

Intermountain Medical Center, Murray, Utah

More Information

Responsible Party:	Intermountain Medical Center ( Alan H. Morris )
Study ID Numbers:	N01-HC-45210-2, HHSN268200425210C
Study First Received:	April 7, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00654797
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Center for Research Resources (NCRR):

Glucose
Insulin
computer
critical care

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Critical Illness

Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Disease Attributes
Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009