Healthy Volunteers Clinical Trial
Official title:
Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers
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
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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