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Sponsored by: |
National Center for Research Resources (NCRR) |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00654797 |
The Purpose of this study is to:
Condition | Intervention | Phase |
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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 Intensive Care Unit Patients-Second Phase (Phase-2): Distribution and Implementation of Validated eProtocol-Insulin in Naïve ICUs |
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 |
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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.
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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.
Ages Eligible for Study: | 1 Month and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alan Morris, MD | 801-408-1610 | Alan.Morris@intermountainmail.org |
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 |
Principal Investigator: | Alan H Morris, MD | Intermountain Medical Center, Murray, Utah |
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 History of Changes |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Glucose Insulin computer critical care |
Hypoglycemic Agents Metabolic Diseases Hyperglycemia Critical Illness |
Glucose Metabolism Disorders Metabolic Disorder Insulin |
Disease Attributes Hypoglycemic Agents Metabolic Diseases Pathologic Processes Hyperglycemia |
Critical Illness Physiological Effects of Drugs Glucose Metabolism Disorders Pharmacologic Actions Insulin |