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临床试验/NCT00636714
NCT00636714已完成4 期

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

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Mean area-under-the curve for blood glucose within target per shift

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult CVICU pts
  • •requires insulin therapy for glucose greater than 8 mmol/L
  • •anticipated ICU stay > 24 hrs
  • •not in DKA/HHNK
  • •mechanically ventilated

排除标准

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

研究组 & 干预措施

Nurse-directed

Experimental

Using nursing judgement to control blood glucose

干预措施: Nursing judgement (Behavioral)

Nomogram-directed

Active Comparator

Blood glucose control directed by pre-approved paper nomogram

干预措施: Nomogram (Behavioral)

结局指标

主要结局

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

时间窗: over 12 hours

次要结局

  • Hypoglycemia frequency(per shift)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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