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OpenTrials
Completed

NCT Number: NCT00636714

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: over 12 hours

Secondary outcomes

  1. Hypoglycemia frequency

    Time frame: per shift

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 14, 2008
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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