NCT00654797

Brief Summary

The Purpose of this study is to:

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

10.3 years

First QC Date

April 7, 2008

Last Update Submit

February 24, 2015

Conditions

Critically IllHyperglycemia

Keywords

GlucoseInsulincomputercritical care

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (4)

  • Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)

    1 year

  • Time to reach the 80-110 mg/dl target

    1 year

  • Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)

    1 year

  • Proportion of glucose values 41-60 mg/dl

    1 year

Study Arms (1)

eProtocol

EXPERIMENTAL
Procedure: glucose control with computer generated recommendations

Interventions

glucose control with computer generated recommendationsPROCEDURE

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.

eProtocol

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Childrens Hospital Centeral California

Madera, California, United States

RECRUITING

Childrens Hospital of Minnesota - St. Paul

Saint Paul, Minnesota, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

RECRUITING

Cornell University Medical College

New York, New York, United States

RECRUITING

Mount Sinai Hospital

New York, New York, United States

RECRUITING

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

RECRUITING

Ohio State University

Columbus, Ohio, United States

RECRUITING

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

RECRUITING

Ben Taub General Hospital

Houston, Texas, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

MeSH Terms

Conditions

Critical IllnessHyperglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Alan H Morris, MD

    Intermountain Medical Center, Murray, Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Morris, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 9, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

US(10)