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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperglycemia in Critically Ill Patients

Intervention / Treatment
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* Behavioral: Nursing judgement
* Behavioral: Nomogram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia frequency |  | per shift | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive insulin therapy, glucose control, nurse directed, nomogram directed