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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01889823
Other study ID # OX1
Secondary ID
Status Completed
Phase Phase 1
First received June 26, 2013
Last updated March 24, 2015
Start date June 2013
Est. completion date December 2014

Study information

Verified date March 2015
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Independent Ethics Committee
Study type Interventional

Clinical Trial 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 activation of Hypoxia Inducible Factor, a transcription factor that is known to activate many cell systems aimed at cell survival, including the inflammatory response. The anti-inflammatory effects of hyperoxia could be the annihilation of Hypoxia Inducible Factor, but also a decrease in inflammation due to oxygen toxicity resulting in a decrease in clearance of pathogens. These effects have been sparsely studied in humans. Therefore, we hypothesize that hypoxia results in an increase in Hypoxia Inducible Factor in circulating leukocytes and increases inflammatory reactions, whereas hyperoxia decreases these reactions.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2014
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Age =18 and =35 yrs

- Male

- Healthy

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Hypoxia
Subjects will be breathing an individualized mix of nitrogen and room air titrated to an oxygen saturation of 80-85%.
Hyperoxia
Subjects will be breathing 100% oxygen

Locations

Country Name City State
Netherlands Intensive Care Medicine, Radboud University Nijmegen Medical Centre Nijmegen Nijmegen, Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypoxia Inducible Factor 1 alpha in circulating leukocytes Hypoxia Inducible Factor 1 alpha in circulating neutrophils, lymphocytes and monocytes as measured with flow cytometry 24 hours No
Secondary Hypoxia Inducible Factor mRNA and anti Hypoxia Inducible Factor mRNA in circulating leukocytes 24 hours No
Secondary Reactive Oxygen Species in circulating leukocytes ROS in circulating leukocytes, subclassified in neutrophils and monocytes 24 hours No
Secondary Phagocytic function of circulating leukocytes 24 hours No
Secondary cytokine production after ex vivo stimulation of leukocytes 24 hours No
Secondary circulating cytokines (including but not limited to IL-6, IL-10, IL-1RA) 24 hours No
Secondary Hemodynamic parameters Blood pressure, heart frequency, cardiac output measurement 24 hours No
Secondary ventilatory response Measures of ventilation: respiratory rate, blood gas changes 24 hours No
Secondary adenosine metabolism urine and plasma adenosine,adenosine receptor mRNA, purines 24 hours No
Secondary alkaline phosphatase 24 hours No
Secondary cognitive function neuropsychologic assessment of cognitive function 24 hours No
Secondary Hepcidin and iron parameters 24 hours No
Secondary catecholamines adrenaline, noradrenaline and dopamine 24 hours No
Secondary Neutrophil function 24 hours No
Secondary body temperature 24 hours No
Secondary oxygen saturation and PaO2 24 hours No
Secondary subjective symptoms 24 hours No
Secondary high sensitive troponin 24 hours No
Secondary iFABP 24 hours No
Secondary Brain specific proteins 24 hours No
Secondary endocan 24 hours No
Secondary adrenomedullin 24 hours No
Secondary EPO 24 hours No
Secondary VEGF 24 hours No
Secondary Heart rate variability 24 hours No
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