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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clarence Chant, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00636714
First received: March 7, 2008
Last updated: February 29, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014