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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00654797
Other study ID # N01-HC-45210-2
Secondary ID HHSN268200425210
Status Recruiting
Phase Phase 2
First received April 7, 2008
Last updated February 24, 2015
Start date September 2007
Est. completion date December 2018

Study information

Verified date February 2015
Source Intermountain Health Care, Inc.
Contact Alan Morris, MD
Phone 801-408-1610
Email Alan.Morris@intermountainmail.org
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The Purpose of this study is to:

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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 1 Month and older
Eligibility 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)

Study Design

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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Ohio State University Columbus Ohio
United States University of Texas Medical Branch at Galveston Galveston Texas
United States Ben Taub General Hospital Houston Texas
United States MD Anderson Cancer Center Houston Texas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Childrens Hospital Centeral California Madera California
United States Cornell University Medical College New York New York
United States Mount Sinai Hospital New York New York
United States Childrens Hospital of Minnesota - St. Paul St. Paul Minnesota
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy) 1 year Yes
Secondary Time to reach the 80-110 mg/dl target 1 year Yes
Secondary Nursing perception of workload in comparison to ordinary care (efficacy and feasibility) 1 year No
Secondary Proportion of glucose values 41-60 mg/dl 1 year No
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