Effects of Oxygen Status on Endotoxemia Induced Inflammation and Hypoxia Inducible Factor-1α

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Oxygen is a widely available gas that is cheap, easy to get and extensively used in medicine. From animal studies it has become apparent that increasing or lowering the degree of oxygen in the blood, the inflammatory response can be altered. We will investigate of this is also true in humans by increasing, lowering or keeping oxygen levels normal while giving healthy subjects a short inflammatory stimulus.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University

Criteria

Inclusion Criteria:

• Written informed consent to participate in this trial

• Male subjects aged 18 to 35 years inclusive

• Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters

Exclusion Criteria:

• Use of any medication(including herbal remedies and vitamin/mineral supplements) or recreational drugs within 7 days prior to profiling day

• Smoking

• Use of caffeine, or alcohol or within 1 day prior to profiling day

• Previous participation in a trial where LPS was administered

• Surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day

• Participation in another clinical trial within 3 months prior to profiling day.

• History, signs or symptoms of cardiovascular disease

• An implant that in the opinion of the investigator may make invasive procedures risky for the subject due to the increased risks associated with a possible infection.

• Subject has an implanted active cardiac device (ICD, IPG and/or CRT) Implanted active neurostimulation device

• Subject has internal jugular vein that cannot be accessed

• History of vaso-vagal collapse or of orthostatic hypotension

• History of atrial or ventricular arrhythmia

• Resting pulse rate ≤45 or ≥100 beats / min

• Hypertension (RR systolic >160 or RR diastolic >90)

• Hypotension (RR systolic <100 or RR diastolic <50)

• Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block

• Subject is diagnosed with epilepsy or history of seizures

• Renal impairment: plasma creatinine >120 μmol/L

• Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L

• Coagulation abnormalities: APTT or PT > 1.5 times the reference range

• History of asthma

• Immuno-deficiency CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 2 weeks before profiling day

• Known or suspected of not being able to comply with the trial protocol - Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.