Recruitment

Recruitment Status
Completed

Inclusion Criterias

Healthy
Male
Age ≥18 and ≤35 yrs
Healthy
Male
Age ≥18 and ≤35 yrs

Exclusion Criterias

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

Summary

Conditions
  • Hyperoxia
  • Hypoxia
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 35 years
Gender
Only males

Inclusion Criterias

Healthy
Male
Age ≥18 and ≤35 yrs
Healthy
Male
Age ≥18 and ≤35 yrs

Exclusion Criterias

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

Locations

Nijmegen, Nijmegen, Gelderland, 6500 HB
Nijmegen, Nijmegen, Gelderland, 6500 HB

Tracking Information

NCT #
NCT01889823
Collaborators
Not Provided
Investigators
  • Principal Investigator: Dorien Kiers, MD Intensive Care Medicine, Radboud University Nijmegen Medical Centre Study Director: Peter Pickkers, MD,PhD Intensive Care Medicine, Radboud University Nijmegen Medical Centre
  • Dorien Kiers, MD Intensive Care Medicine, Radboud University Nijmegen Medical Centre Study Director: Peter Pickkers, MD,PhD Intensive Care Medicine, Radboud University Nijmegen Medical Centre