Healthy Volunteers
Conditions
Keywords
Xenon-inhalation, Erythropoetin, Pharmakokinetic, Pharmacodynamic, Hemodynamic parameters, Inflammatory parameters, Growth factors, Oxidative stress parameters
Brief summary
The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation. Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood
Detailed description
Xenon-gas is an approved anesthetic by the EMEA and is used for a balanced anesthesia in combination with opioids for adults with a american society of anesthesiology classification ASA ≤ III. Several clinical and pre-clinical studies have shown a positive effect of xenon on several organ functions such as in brain, kidneys and heart. In two studies, an enhanced expression of hypoxia inducible factor-1α (HIF-1α) could be shown in animal kidneys and kidney cells. Interestingly, HIF-1α leads to an enhanced formation of erythropoetin (EPO). This might result in an enhanced oxygen transport capacity and an enhanced oxygen-level after xenon-treatment. Aim of the project is to analyze the effect of xenon-inhalation on circulating erythropoetin-level in blood of healthy volunteers in a randomized controlled pilot study. Besides, other positive stimulating factors for erythropoiesis (such as HIFa stabilizing factors) and growth factors (such as fibroblast growth factors (FGFs), hepatocyte growth factor (HGF), mechano growth factors (MGFs), platelet-derived growth factors (PDGFs), vascular endothelial growth factors (VEGFs)) shall be analyzed.
Interventions
DRUGXenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
DRUGAer medicinalis Linde 100%
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male subjects * Age: \> 18 years * legally competent to sign * without any known medical condition or medication prescribed at the University Hospital RWTH Aachen, Germany * Persons that are able and willing to understand and follow the instructions of the study personnel * Signed informed consent
Exclusion criteria
* Smoker, alcoholic or person who regularly consumes drugs or medication * Persons with a medical condition that is contraindicated with the planned treatment * Known hypersensitivity against xenon * Persons not legally competent to sign * Simultaneous participation at any other trial * Blood-loss due to trauma during the period of the study or 2 months previous * Blood donation during the period of the study or 2 months previous
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total | up to 216 hrs after first xenon-application | Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total. Timepoints of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy | up to 216 hrs after the first xenon-application | Timepoints of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) | up to 216 hrs after the first xenon-application | Time points of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation |
| Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growth factors (HIF1α, FGFs, HGF, MGFs, PDGF, VEGF, IL-8, VEGF, MIF, SDF-1a) | up to 216 hrs after the first xenon-application | Timepoints of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation |
| Oxidative stress: total oxidative capacity, peroxide activity, LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM, oLAb (IgG) | up to 216 hrs after the first xenon-application | Time points of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation |
Countries
Germany
Outcome results
None listed