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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


Phase 2
1 Month
N/A
Open (Enrolling)
Both
Critically Ill, Hyperglycemia

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Alan H Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Intermountain Medical Center, Murray, Utah

Authority:

United States: Federal Government

Study ID:

N01-HC-45210-2

NCT ID:

NCT00654797

Start Date:

September 2007

Completion Date:

October 2009

Related Keywords:

  • Critically Ill
  • Hyperglycemia
  • Glucose
  • Insulin
  • computer
  • critical care
  • Critical Illness
  • Hyperglycemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Ben Taub General HospitalHouston, Texas  77030
Ohio State UniversityColumbus, Ohio  43210
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157
University of Texas Medical Branch at GalvestonGalveston, Texas  77555
Mount Sinai HospitalNew York, New York  10029
Childrens Hospital Centeral CaliforniaMadera, California  
Childrens Hospital of Minnesota - St. PaulSt. Paul, Minnesota  
Cornell University Medical CollegeNew York, New York