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

U

Unity Health Toronto

Status and phase

Completed
Phase 4

Conditions

Hyperglycemia in Critically Ill Patients

Treatments

Behavioral: Nursing judgement
Behavioral: Nomogram

Study type

Interventional

Funder types

Other

Identifiers

NCT00636714
REB 07-282c

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Nurse-directed
Experimental group
Description:
Using nursing judgement to control blood glucose
Treatment:
Behavioral: Nursing judgement
Nomogram-directed
Active Comparator group
Description:
Blood glucose control directed by pre-approved paper nomogram
Treatment:
Behavioral: Nomogram

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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