The effects of bilirubin infusion on the innate immune response during human endotoxemia.;A parallel open label placebo controlled pilot study. - LPSBILI

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•-Use of any medication or anti-oxidant vitamin supplements.
•-History of allergic reaction to albumin or any other drug used in the study.
•-Previous spontaneous vagal collapse.
•-History, signs or symptoms of cardiovascular disease.
•-(Family) history of myocardial infarction or stroke under the age of 65 years.
•-Cardiac conduction abnormalities on the ECG consisting of a 1st degree (or higher degree) atrioventricular block or a complex bundle branch block.
•- Hypertension (defined as a repeated measurement of RR systolic > 160 or RR diastolic > 90 mmHg).
•- Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg).
•- Renal impairment (defined as plasma creatinin >120 µmol/l).
•- Liver enzyme abnormalities or positive hepatitis B serology.
•- Subjects with a total bilirubin level above 15 µmol/L and a normal direct bilirubin level suggesting Gilbert Syndrome.
•- Positive HIV serology or any other obvious disease associated with immune deficiency.
•- Febrile illness in the week before the experiment.
•- Participation in a drug trial or donation of blood 3 months prior to the LPS challenge.
•- Inability to understand the nature and extent of the trial and the procedures required.

发起方

niversitair Medisch Centrum Sint Radboud