Hypoxia Clinical Trial
Official title:
Effects of Oxygen Status on Endotoxemia Induced Inflammation and Hypoxia Inducible Factor-1α. A Pilot Proof of Principle Study
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Intensive Care Medicine | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma TNF-alpha concentration following LPS administration | Plasma TNF-a concentration after LPS administration (Area Under Curve); comparison of subjects treated with hypoxia compared to normoxia and hyperoxia compared to hypoxia | 1 day | No |
Secondary | Hypoxia Inducible Factor 1 alpha in circulating leukocytes | Hypoxia Inducible Factor 1 alpha in circulating neutrophils, lymfocytes and monocytes as measured with flow cytometry | 1 day | 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 | 1 day | No | |
Secondary | Phagocytic function of circulating leukocytes | 1 day | No | |
Secondary | cytokine production after ex vivo stimulation of leukocytes | 1 day | No | |
Secondary | circulating cytokines (including but not limited to IL-6, IL-10, IL-1RA) | 1 day | No | |
Secondary | Hemodynamic parameters | Blood pressure, heart frequency, cardiac output measurement | 1 day | No |
Secondary | ventilatory response | Measures of ventilation: respiratory rate, blood gas changes | 1 day | No |
Secondary | adenosine metabolism | urine and plasma adenosine,adenosine receptor mRNA, purines | 1 day | No |
Secondary | alkaline phosphatase | 1 day | No | |
Secondary | cognitive function | neuropsychologic assessment of cognitive function | 1 day | No |
Secondary | Hepcidin and iron parameters | 1 day | No | |
Secondary | catecholamines and cortisol | adrenaline, noradrenaline, dopamine and cortisol | 1 day | No |
Secondary | Neutrophilic function | 1 day | No | |
Secondary | body temperature | 1 day | No | |
Secondary | oxygen saturation and arterial blood gas | 1 | Yes | |
Secondary | subjective symptom scores | 1 day | No | |
Secondary | high sensitive troponine | 1 day | No | |
Secondary | iFABP | 1 day | No | |
Secondary | brain specific proteins | 1 day | No | |
Secondary | endocan | 1 day | No | |
Secondary | downstream targets of HIF | adrenomedullin, VEGF, EPO | 1 day | No |
Secondary | heart rate variability | 1 day | No | |
Secondary | kidney injury markers in plasma and urine | 2 days | No | |
Secondary | microbiome in feces | -1 day untill 1 week | No | |
Secondary | markers of immunoparalysis | monocytic histone 3 lysine 4 trimethylation of the promotor region of pro-inflammatory genes, ex viv production of proinflammatory cytokines, HLA-DR expression on moncytes. | 1 day | No |
Secondary | measures of coagulation and plateletfunction | platelet activation and platelet function, thrombin generation and other coagulation parameters, hematolocial infection profile using hematology analyser | 1 day | No |
Secondary | meausures of coagulation and fibrinolysis | thrombin generation, thrombocyte function, ROTEM, plasmatic coagulation, fibrinolysis parameters | 1 day | No |
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