NL-OMON48466已完成不适用
Determining the fingerprint of endotoxin tolerance - 100LPS study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Written informed consent
- •* Age *18 and *35 yrs
- •* Healthy (as confirmed by medical history, physical examination,
- •electrocardiography, laboratory tests)
排除标准
- •* Pregnancy (confirmed by negative result of pregnancy tests prior to both
- •endotoxin challenges)
- •* Use of any medication
- •* History or signs of atopic syndrome (asthma, rhinitis with medication and/or
- •* Known anaphylaxis or hypersensitivity to the non-investigational products or
- •their excipi-ents.
- •* History or signs of hematological disease:
- •* Thrombocytopenia (<150*10^9/ml) or anemia (for males: hemoglobin < 8.0 mmol/L
- •and for females: hemoglobin < 7.4 mmol/L)
- •* Abnormalities in leukocyte differential counts
- •* History, signs or symptoms of cardiovascular disease, in particular:
- •* Previous spontaneous vagal collapse
- •* History of atrial or ventricular arrhythmia
- •* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree
- •atrioventricular block or a complete left 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 creatinine >120 *mol/l)
- •* Liver enzyme abnormalities (above 2x the upper limit of normal)
- •* Medical history of any disease associated with immune deficiency
- •* Signs of infection (CRP > 20 mg/L, WBC > 12x109/L or < 4 x109/L)
- •* Clinically significant acute illness, including infections, within 1 month of
- •the first endotoxin challenge
- •* Previous (participation in a study with) endotoxin (LPS) administration
- •* Any vaccination within 3 months within of the first endotoxin challenge
- •* Participation in a drug trial or donation of blood within 3 months prior to
- •first endotoxin challenge
- •* Recent hospital admission or surgery with general anesthesia within 3 months
- •prior to first endotoxin challenge
- •* Use of recreational drugs within 1 month of the first endotoxin challenge
- •* Inability to personally provide written informed consent (e.g. for linguistic
- •or mental rea-sons) and/or take part in the study.
研究者
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