Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1 - Full Text View

Sponsored by:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00655460

Purpose

The Purpose of this study is to:

Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.
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

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 ICU Patients:Further Refinement and Validation of eProtocol-Insulin

Resource links provided by NLM:

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

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

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of glucose determinations within the range of 70-110 mg/dl (3.9-6.1 mMol/l) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Nursing perception of workload in comparison to ordinary care [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2006
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:

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 computerized bedside tool will be considered refined if >90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl 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: NCT00655460

Contacts

Contact: Alan H Morris, MD

801-408-1610

Alan.Morris@intermountainmail.org

Locations

United States, Connecticut
Yale University	Completed
New Haven, Connecticut, United States, 05520
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Roy Brower, MD
United States, Massachusetts
Massachusetts General Hospital	Withdrawn
Boston, Massachusetts, United States, 02114
Baystate Medical Center	Active, not recruiting
Springfield, Massachusetts, United States, 01199
United States, North Carolina
Wake Forest Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Robert D Hite, MD
United States, Pennsylvania
Children's Hospital of Philadelphia	Completed
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania State Children's Hospital	Completed
Hersey, Pennsylvania, United States, 17033
United States, Tennessee
Vanderbilt University	Completed
Nashville, Tennessee, United States, 37232
United States, Utah
LDS Hospital	Recruiting
Salt Lake City, Utah, United States, 84143
Principal Investigator: James Orme, MD
Primary Children's Hospital	Completed
Salt Lake City, Utah, United States, 84143
United States, Virginia
University of Virginia	Active, not recruiting
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Alan H Morris, MD

Intermountain Medical Center, Murray, Utah

More Information

No publications provided

Responsible Party:	LDS Hospital, Salt Lake City, UT ( Alan H. Morris )
Study ID Numbers:	N01-HC-45210-1, HHSN268200425210C
Study First Received:	April 7, 2008
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00655460 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

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

Glucose
Insulin
computer
critical care

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Critical Illness

Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Disease Attributes
Hypoglycemic Agents
Metabolic Diseases
Pathologic Processes
Hyperglycemia

Critical Illness
Physiological Effects of Drugs
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 09, 2009