EUCTR2015-003698-13-NL进行中（未招募）不适用
euroinflammation in sepsis encephalopathy: the NINEVEH-study - The NINVEH-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age>50 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Pregnancy or wish to become pregnant within 2 weeks after PET-CT scan.
- •Contra-indication to undergo a CT or MRI scan, including claustrophobia.
- •Unstable hemodynamics or respiration that contra-indicate transport and undergoing PET/MRI imaging.
- •Other causes not related to sepsis that sufficiently explain (relation in time) the onset of delirium such as newly onset severe kidney or liver failure, or severe electrolyte disturbances, severe hypoglycaemia.
- •Delirium coinciding with start of medications known to increase the risk of development of delirium. This will be judged by the delirium expert: e.g. neurologist, geriatrician, or senior delirium researcher (e.g. based on the type of drug known to trigger delirium and the temporal relationship between start of the medication and onset of delirium).
- •Presence of delirium before onset of infection.
- •Age < 50 years.
- •Moribund patients or patients on palliative care.
- •Brain or spinal surgery within the last 3 months.
- •Meningitis or brain infection within the 6 months.
- •Pre-existing cognitive impairment interfering with the ability to understand informational material about this research project.
- •Presence of a CSF catheter or shunt.
- •Patients with known brain tumours.
- •Patients with brain injury (e.g. acute stroke, brain trauma, or subarachnoid haemorrhage) within the last 3 months.
- •Chronic (>6 weeks) use of immunosuppressive agents.
- •Concomitant diseases resulting in severe immunosuppression (e.g. HIV).
- •Chronic use of neuroleptics, defined as pre-hospital use.
- •Patients that do not speak Dutch or have disabilities that prevent accurate delirium diagnosis.
- •Analphabetic patients.
研究者
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