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

NCT00636714 | Completed Phase 4

• 1 other identifier: REB 07-282c
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  over 12 hours

Secondary Outcomes (1)

• Hypoglycemia frequency

  per shift

Study Arms (2)

Nurse-directed

EXPERIMENTAL

Using nursing judgement to control blood glucose

Behavioral: Nursing judgement

Nomogram-directed

ACTIVE COMPARATOR

Blood glucose control directed by pre-approved paper nomogram

Behavioral: Nomogram

Interventions

Nursing judgement BEHAVIORAL

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

Nurse-directed

Nomogram 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

Nomogram-directed

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• MD refusal
• no IV access for insulin
• allergy to insulin
• DNR or moribund as determined by the clinical team

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related 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.

  PMID: 22751370 RESULT

MeSH Terms

Interventions

Nomograms

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Models, Statistical; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Models, Theoretical; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Clarence Chant, PharmD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 5, 2023

Record last verified: 2017-01

Locations

CA (1)