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

June 1, 2023 updated by: Unity Health Toronto

Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse-directed
Using nursing judgement to control blood glucose
Behavioral: Nursing judgement
Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L
Active Comparator: Nomogram-directed
Blood glucose control directed by pre-approved paper nomogram
Behavioral: Nomogram
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean area-under-the curve for blood glucose within target per shift
Time Frame: over 12 hours
over 12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemia frequency
Time Frame: per shift
per shift

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Clarence Chant, PharmD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimated)

March 14, 2008

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB 07-282c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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