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Clinical Trials/NCT00636714
NCT00636714CompletedPhase 4

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

Unity Health Toronto2 sites in 1 country40 target enrollmentStarted: January 2008Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Mean area-under-the curve for blood glucose within target per shift

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: over 12 hours

Secondary Outcomes

  • Hypoglycemia frequency(per shift)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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