Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperglycemia in Critically Ill Patients |
Behavioral: Nursing judgement Behavioral: Nomogram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU |
- Mean area-under-the curve for blood glucose within target per shift [ Time Frame: over 12 hours ] [ Designated as safety issue: No ]
- Hypoglycemia frequency [ Time Frame: per shift ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nurse-directed
Using nursing judgement to control blood glucose
|
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
|
|
Active Comparator: Nomogram-directed
Blood glucose control directed by pre-approved paper nomogram
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Canada, Ontario | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B1W8 | |
| Principal Investigator: | Clarence Chant, PharmD | St. Michael's Hospital, Toronto |
More Information
No publications provided
| Responsible Party: | Clarence Chant, Clinical Pharmacy Specialist, St. Michael's Hospital, Toronto |
| ClinicalTrials.gov Identifier: | NCT00636714 History of Changes |
| Other Study ID Numbers: | REB 07-282c |
| Study First Received: | March 7, 2008 |
| Last Updated: | February 29, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by St. Michael's Hospital, Toronto:
|
intensive insulin therapy glucose control nurse directed nomogram directed |
Additional relevant MeSH terms:
|
Critical Illness Hyperglycemia Disease Attributes |
Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013