EUCTR2015-002706-36-NL进行中（未招募）1 期
The effects of different vasopressors on the innate immune response during experimental human endotoxemia, a pilot proof-of-principle study - Effects of vasopressors on immune response
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 40
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
- •-Written informed consent
- •-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 40
- •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
- •-Previous spontaneous vagal collapse
- •-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)
- •-Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
- •-Renal impairment (defined as plasma creatinin >120 µmol/l)
- •-Liver enzyme abnormalities or positive hepatitis serology
- •-Medical history of any disease associated with immune deficiency
- •-CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within
- •4 weeks before endotoxin administration
- •-Participation in a drug trial or donation of blood 3 months prior to the LPS challenge
- •-Use of recreational drugs within 7 days prior to experiment day
- •-Recent hospital admission or surgery with general anaesthesia (<3 months)
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