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

NCT ID: NCT00636714

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-04-30

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.

Conditions

Hyperglycemia in Critically Ill Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nurse-directed

Using nursing judgement to control blood glucose

Group Type: EXPERIMENTAL

Nursing judgement

Intervention Type: BEHAVIORAL

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

Nomogram-directed

Blood glucose control directed by pre-approved paper nomogram

Group Type: ACTIVE_COMPARATOR

Nomogram

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clarence Chant, PharmD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 22751370 (View on PubMed)

Other Identifiers

REB 07-282c

Identifier Type: -

Identifier Source: org_study_id