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临床试验/NCT00115479
NCT00115479已完成2 期

KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

KU Leuven2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2002年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
KU Leuven
入组人数
1,200
试验地点
2
主要终点
mortality

研究概览

简要总结

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

详细描述

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

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

入选标准

  • Adults admitted to ICU and anticipated to require intensive care for at least a few days

排除标准

  • Expected short ICU stay
  • Therapy restricted upon admission
  • Surgical ICU patients
  • Other studies
  • Below 18 years
  • Pregnancy

结局指标

主要结局

mortality

次要结局

  • mechanical ventilatory support-dependency
  • stay in Intensive Care Unit (ICU)
  • stay in hospital
  • organ failure
  • morbidity
  • a long-term follow up is planned to take place 6 and 12 months after hospital discharge

研究者

发起方
KU Leuven
申办方类型
Other

研究点 (2)

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