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临床试验/NCT05505396
NCT05505396已完成不适用

Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury in the Intensive Care Unit - a Prospective, Observational Cohort Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2022年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
459
试验地点
1
主要终点
Functional outcome at 6 months as evaluated by the modified Rankin Scale.

研究概览

简要总结

This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome.

Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years
  • Admission to the neurointensive care unit at Rigshospitalet
  • Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions

排除标准

  • Brain death before inclusion
  • Closest relatives do not understand written and spoken Danish or English

结局指标

主要结局

Functional outcome at 6 months as evaluated by the modified Rankin Scale.

时间窗: 6 months after admission.

Modified Rankin Scale ranges from 0-6, where 0 is the best and 6 is the worst outcome.

次要结局

  • All-cause mortality at 6 months (dichotomous).(6 months after admission.)
  • Length of stay in the neuro-ICU (continuous).(Day of discharge, typically 1-30 days after admission.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra Vassilieva

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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