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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00636714
Enrollment
40
Registered
2008-03-14
Start date
2008-01-31
Completion date
2010-04-30
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia in Critically Ill Patients

Keywords

intensive insulin therapy, glucose control, nurse directed, nomogram directed

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.

Interventions

BEHAVIORALNursing judgement

Based on the nursing judgement, titrate insulin infusion and determine glucose check frequency to achieve a target glucose of 5-8 mmol/L

BEHAVIORALNomogram

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

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mean area-under-the curve for blood glucose within target per shiftover 12 hours

Secondary

MeasureTime frame
Hypoglycemia frequencyper shift

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026