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临床试验/NCT02237833
NCT02237833终止不适用

Cerebral Oxygenation in Septic Patients Using Vasopressors - The Conscious Study

Karl-Andre Wian1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
15
试验地点
1
主要终点
Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours

研究概览

简要总结

The purpose of this study is to reveal if higher doses of vasopressors in septic shock patients correlates with cerebral vasoconstriction and lower cerebral oximetry.

详细描述

The mortality with septic shock is high. Treatment includes antibiotics, intravenous fluid and drugs for circulatory support, especially the vasopressor norepinephrine. Fluids and drugs for circulatory support are to restore adequate organ perfusion. Inadequate oxygenation of the brain can give neurologic damage. Traditionally treatment is guided by surrogate markers like arterial and central venous pressure. Cerebral oximetry is a non-invasive method which measures cerebral saturation of oxygen, SCO2, and thereby expresses regional cerebral perfusion. By registering cerebral oxymetry on patients treated with vasopressors for septic shock we want to reveal if higher doses of vasopressor correlates with cerebral vasoconstriction and lower cerebral oximetry.

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

  • 18 years or older
  • Septic shock patients in ICU department requiring vasopressor therapy

排除标准

  • Damage to the frontal lobes corresponding to the area where SCO2 is monitored
  • Patients in pharmacological studies
  • Patients with known intracranial vascular anomalies or cerebral aneurysms
  • Patients where vasoactive medication is started before cerebral oxymetry is established
  • Patients with known neurological disease
  • Patients with undergone cerebral insult, transient ischemic attack or carotid stenosis
  • Patients who have been resuscitated after cardiac arrest in connection with this hospital stay
  • Patients with a body temperature below 35 degrees Celsius when establishing monitoring

结局指标

主要结局

Number of minutes of SCO2-values lower than 50 or reduced by 20% during 24 hours

时间窗: 24 hours

SCO2 will be measured before initiating vasopressor therapy. Thereafter SCO2 are updated every 2 seconds and is measured for 24 hours.

次要结局

  • Incidence of acute myocardial infarction(Hospital discharge, expected 12 days at average)
  • Use of vasopressors/inotropes(Discharge from ICU, expected 5 days at average)
  • Length of stay in ICU(Discharge from ICU, expected 5 days at average)
  • Incidence of organ failure(Discharge from ICU, expected 5 days at average)
  • Fluid balance(24 hours)
  • Length of stay in hospital(Discharge from hospital, expected 10 days at average)

研究者

发起方
Karl-Andre Wian
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karl-Andre Wian

MD

Sykehuset i Vestfold HF

研究点 (1)

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