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临床试验/EUCTR2013-002390-21-NL
EUCTR2013-002390-21-NL进行中(未招募)1 期

Effects of oxygen status on endotoxemia induced inflammation and Hypoxia Inducible Factor 1-a. A pilot proof of principle study.

Radboud University Nijmegen Medical Centre0 个研究点目标入组 30 人开始时间: 2013年8月20日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
30

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
Male

入选标准

  • Age>18 and <35 yrs
  • 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 30
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -Use of any medication
  • -History, signs or symptoms of cardiovascular disease
  • -History of atrial or ventricular arrhythmia
  • -(Family) history of myocardial infarction or stroke under the age of 65 years
  • -Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block
  • -Hypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg)
  • -Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)
  • -Renal impairment (defined as plasma creatinine >120 µmol/l)
  • -Liver enzyme abnormalities alkaline phosphatase>230 U/L and/or ALT>90 U/L
  • -Medical history of any obvious disease associated with immune deficiency
  • -CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
  • -Participation in a drug trial or donation of blood 3 months prior to the experiment
  • -Pre-existent pulmonary diseases, including asthma
  • -Use of recreational drugs within 21 days prior to experiment day
  • -Visit to altitude >1500m within 4 weeks prior to the experiment
  • -Air travel with flight time over 3 hours within 4 weeks prior to the experiment
  • -History of acute mountain sickness
  • -Recent hospital admission or surgery with general anaesthesia (<3 months)
  • -Claustrophobia
  • -Feelings of discomfort during a 10 minute test wearing the transparent respiratory helmet at the screening visit

研究者

发起方
Radboud University Nijmegen Medical Centre

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