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Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients

Primary Purpose

Hyperglycemia in Critically Ill Patients

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Nursing judgement
Nomogram
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia in Critically Ill Patients focused on measuring intensive insulin therapy, glucose control, nurse directed, nomogram directed

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients:

  • adult CVICU pts
  • requires insulin therapy for glucose greater than 8 mmol/L
  • anticipated ICU stay > 24 hrs
  • not in DKA/HHNK
  • mechanically ventilated

Exclusion Criteria:

  • MD refusal
  • no IV access for insulin
  • allergy to insulin
  • DNR or moribund as determined by the clinical team

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-directed

Nomogram-directed

Arm Description

Using nursing judgement to control blood glucose

Blood glucose control directed by pre-approved paper nomogram

Outcomes

Primary Outcome Measures

Mean area-under-the curve for blood glucose within target per shift

Secondary Outcome Measures

Hypoglycemia frequency

Full Information

First Posted
March 7, 2008
Last Updated
June 1, 2023
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00636714
Brief Title
Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients
Official Title
Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves lives. However, this is difficult to do in the ICU and carries risks of lowering the blood sugar too much. In addition, the best way to achieve this control is not known. Many strict nomograms that provide a standardized approach for nurses have been developed and validated, including one here at SMH. However, these nomograms cannot apply to all patients at all times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the bedside constantly, are very familiar with their patient's needs, and have decades of experience in titrating medication doses without a nomogram to achieve a pre-determined response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside nurse has bought into the importance of the concept of tight glucose control and have been introduced to the nomogram here at SMH, their experience and intuition may be more adaptable to the changing needs of the patient than an inflexible paper nomogram. This study will compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse directed) in order to determine whether the nomogram should continue to be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia in Critically Ill Patients
Keywords
intensive insulin therapy, glucose control, nurse directed, nomogram directed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse-directed
Arm Type
Experimental
Arm Description
Using nursing judgement to control blood glucose
Arm Title
Nomogram-directed
Arm Type
Active Comparator
Arm Description
Blood glucose control directed by pre-approved paper nomogram
Intervention Type
Behavioral
Intervention Name(s)
Nursing judgement
Intervention Description
Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L
Intervention Type
Behavioral
Intervention Name(s)
Nomogram
Intervention Description
A preprinted order outlining a nomogram with instructions for how insulin infusion should be changed based on measured glucose values and how frequent the glucose checks should be
Primary Outcome Measure Information:
Title
Mean area-under-the curve for blood glucose within target per shift
Time Frame
over 12 hours
Secondary Outcome Measure Information:
Title
Hypoglycemia frequency
Time Frame
per shift

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients: adult CVICU pts requires insulin therapy for glucose greater than 8 mmol/L anticipated ICU stay > 24 hrs not in DKA/HHNK mechanically ventilated Exclusion Criteria: MD refusal no IV access for insulin allergy to insulin DNR or moribund as determined by the clinical team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarence Chant, PharmD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22751370
Citation
Chant C, Mustard M, Thorpe KE, Friedrich JO. Nurse- vs nomogram-directed glucose control in a cardiovascular intensive care unit. Am J Crit Care. 2012 Jul;21(4):270-8. doi: 10.4037/ajcc2012713.
Results Reference
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Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients

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