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临床试验/NCT00472381
NCT00472381已完成2 期

Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
180
试验地点
1
主要终点
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.

研究概览

简要总结

Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.

详细描述

It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

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
None

入排标准

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

入选标准

  • Age over 18 years
  • Carotid territory stroke
  • MRI performed in the first five hours of stroke onset
  • Baseline National Institutes of Health Stroke Scale (NIHSS) > 4 or < 26
  • Time between MRI and treatment under one hour

排除标准

  • Pre-existing Modified Rankin Scale of three or higher
  • Advanced or terminal illness with risk of death in the next 6 months, addiction

研究组 & 干预措施

2

Experimental

Insulin

干预措施: Insulin (Drug)

结局指标

主要结局

Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.

时间窗: 24 hours

次要结局

  • Modified Rankin Scale at three months(three months)
  • Magnetic resonance imaging (MRI) infarct growth at one day(one day)
  • Percentage of patients with hypoglycaemic event (< 3 mmol/l)(during the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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