Status:
COMPLETED
Effects of Oxygen Status on Hypoxia Inducible Factor 1-α and Inflammation. A Pilot Proof of Principle Study.
Lead Sponsor:
Radboud University Medical Center
Conditions:
Hypoxia
Hyperoxia
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
It has been shown in in vitro and animal models that hypoxia can have pro-inflammatory effects and hyperoxia can have anti-inflammatory effects. The pro-inflammatory effect could be the result of acti...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤35 yrs
- Male
- Healthy
Exclusion
- Use of any medication
- Smoking
- History, signs or symptoms of cardiovascular disease
- 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 mmHg)
- Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50 mmHg)
- Renal impairment (defined as plasma creatinine \>120 μmol/l)
- Liver enzyme abnormalities alkaline phosphatase\>230 U/L and/or ALT\>90 U/L
- Medical history of any obvious disease associated with immune deficiency
- CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day
- Participation in a drug trial or donation of blood 3 months prior to the experiment
- Pre-existent lung disease or asthma
- Use of recreational drugs within 21 days prior to experiment day
- Visit to altitude \>1500m within 4 weeks prior to the experiment
- Air travel with flight time over 3 hours within 4 weeks prior to the experiment
- History of acute mountain sickness
- Recent hospital admission or surgery with general anaesthesia (\<3 months)
- Claustrophobia
- Feelings of discomfort during a 10 minute test wearing the transparent respiratory helmet at the screening visit
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01889823
Start Date
June 1 2013
End Date
December 1 2014
Last Update
March 25 2015
Active Locations (1)
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1
Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Nijmegen, Gelderland, Netherlands, 6500 HB