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临床试验/NCT03949738
NCT03949738已完成不适用

Cerebrovascular Hemodynamics and Neurocognitive Outcome in Patients With Acute Respiratory Distress Syndrome.

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年12月1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
66
试验地点
1
主要终点
COx

研究概览

简要总结

The acute respiratory distress syndrome (ARDS) is a life-threatening disease with functional impairment of the lung. It is characterized by an excessive inflammatory response of lung tissue, capillaries, and blood vessels and is associated with high mortality. Patients who survive the acute phase of this critical disease often suffer from long-term physical, psychological, and mental sequelae, as well as persistent cognitive deficits.

In healthy individuals, autoregulatory mechanisms of the intracranial blood vessels keep blood supply to the brain independent of fluctuations in systemic blood pressure. In the case of a serious illness, these mechanisms of autoregulation may be impaired, which may favor cerebral hypoperfusion. Impairment of cerebrovascular hemodynamics can lead to neuronal damage in short and long term.

The aim of this project is to investigate cerebrovascular autoregulation in adult patients with ARDS and to evaluate the cognitive outcome at 3, 6 and 12 months after discharge from the intensive care unit.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 未提供

排除标准

  • Pre-existing neurological diseases with known intracranial pathology
  • Cerebrovascular disorders, including hemodynamically relevant extracranial vascular stenoses

结局指标

主要结局

COx

时间窗: Assessment for 60 minutes per day during the acute phase of ARDS (maximum 14 days after ARDS onset).

Cerebral Oximetry Index (COx) as a moving correlation between arterial blood pressure and cerebral oximetry with a range from -1 to +1. A COx above 0.3 is defined as impaired cerebrovascular autoregulation. The minutes with COX above 0.3 will be assessed.

次要结局

  • The Short Form (36) Health Survey (SF-36)(3, 6 and 12 months after discharge from ICU.)
  • Cognitive Failures Questionnaire (CFQ)(3, 6 and 12 months after discharge from ICU.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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