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

Hyperglycemia in Critically Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636714
• Other study ID #: REB 07-282c
• Status: Completed
• Phase: Phase 4
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2017
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia
• Hyperglycemia in Critically Ill Patients

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Chant C, Mustard M, Thorpe KE, Friedrich JO. Nurse- vs nomogram-directed glucose control in a cardiovascular intensive care unit. Am J Crit Care. 2012 Jul;21(4):270-8. doi: 10.4037/ajcc2012713. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean area-under-the curve for blood glucose within target per shift		over 12 hours
Secondary	Hypoglycemia frequency		per shift