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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00655460
First received: April 7, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Critically Ill
Hyperglycemia
Procedure: glucose control with computer generated recommendations
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Experimental: eProtocol 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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pennsylvania State Children's Hospital Completed
Hersey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia Completed
Philadelphia, Pennsylvania, United States, 19104
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
Investigators
Principal Investigator: Alan H Morris, MD Intermountain Medical Center, Murray, Utah
  More Information

No publications provided

Responsible Party: Alan H. Morris, LDS Hospital, Salt Lake City, UT
ClinicalTrials.gov Identifier: NCT00655460     History of Changes
Other Study ID Numbers: N01-HC-45210-1, HHSN268200425210C
Study First Received: April 7, 2008
Last Updated: April 7, 2008
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

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 29, 2014