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临床试验/NCT03173196
NCT03173196已完成不适用

Prospective Analysis of the Occurrence and Severity of Septic Encephalopathy in Patients With Severe Sepsis or Septic Shock, Including Non-invasive Multispectral Sonography

University of Rostock1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score

研究概览

简要总结

The patients of the group "sepsis" are measured several times with the non-invasive multi-spectral sonography (Sonovum "ACG-Diagnosesystem") (days 1, 3, 7 and 14). The patients of the group "control" are measured on days 1 and 3 with the system. A measurement takes 3 minutes. For this purpose two ultrasound heads are placed above the patient's ears and fixed with an all-head harness. The device is certified for CE application. There are no known health risks of ultrasound in humans.

详细描述

Sepsis with multiorgan failure is one of the most common diseases in intensive care units and is at the top of the world of causes of death. In addition to increasingly serious sepsis by multidrug-resistant pathogens, neurological symptoms are frequently recorded in the systemic manifestation of the disease pattern. Septic encephalopathy (SE) is usually an early cerebral sign of the developing sepsis, often before other clinically as well as diagnostically detectable findings such as fever ascent, hypotonia or laboratory chemical infections. Therefore, the SE is a clinically important parameter, also because after the sepsis, cerebral functional restrictions such as cognitive disorders can persist in the long term.

Therefore, on day 1, 3, 7 and 14 the patients are measured with the ACG-system as well as determined different scores of the patients: CAM-ICU (Confusion Assessment Method - Intensive Care Unit) and ICDSC (Intensive Care Delirium Screening Checklist) for the neurological outcome; Apache (Acute Physiology And Chronic Health Evaluation) II for mortality and SOFA (Sepsis-related Organ Failure Assessment Score) for organ failure.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Severe sepsis or septic shock
  • Clinical suspicion of septic encephalopathy
  • consent to the study by the patient or legal representative
  • stay in intensive care unit for at least 24 hours without the presence of a septic disease and without clinical guidance for an SE

排除标准

  • Inability to consent to participation in the research project or rejection by patients or legal representatives
  • existence of other causes of delir other than sepsis (e.g., withdrawal)
  • Infrequent prognosis (expected death in ≤ 12 hours despite maximum therapy)

结局指标

主要结局

Principal Components analysis vs ICDSC / SOFA (Sepsis-related Organ Failure Assessment Score)-Score

时间窗: Day 1

after genetic algorithm to find two components

Principal Components analysis vs ICDSC (Intensive Care Delirium Screening Checklist)-Score

时间窗: Day 1

after genetic algorithm to find two components

次要结局

  • ICDSC Score(Day 3)
  • SOFA Score(Day 3)

研究者

发起方
University of Rostock
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Martin Sauer, MD

Deputy of the perioperative intensive care units

University of Rostock

研究点 (1)

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