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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636714
First Posted: March 14, 2008
Last Update Posted: January 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clarence Chant, St. Michael's Hospital, Toronto
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU

Resource links provided by NLM:


Further study details as provided by Clarence Chant, St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Mean area-under-the curve for blood glucose within target per shift [ Time Frame: over 12 hours ]

Secondary Outcome Measures:
  • Hypoglycemia frequency [ Time Frame: per shift ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636714


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Clarence Chant, PharmD St. Michael's Hospital, Toronto
  More Information

Publications:
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
First Submitted: March 7, 2008
First Posted: March 14, 2008
Last Update Posted: January 5, 2017
Last Verified: January 2017

Keywords provided by Clarence Chant, 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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs