Clinical trial NCT02129400: Influence on Erythropoetin-level by Xenon
Official title: Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: Xenon-inhalation
Erythropoetin
Pharmakokinetic
Pharmacodynamic
Hemodynamic parameters
Inflammatory parameters
Growth factors
Oxidative stress parameters
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total
timeFrame: up to 216 hrs after first xenon-application
Secondary outcomes:
measure: First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy
timeFrame: up to 216 hrs after the first xenon-application
Other outcomes:
measure: Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2)
timeFrame: up to 216 hrs after the first xenon-application
measure: Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growth factors (HIF1α, FGFs, HGF, MGFs, PDGF, VEGF, IL-8, VEGF, MIF, SDF-1a)
timeFrame: up to 216 hrs after the first xenon-application
measure: Oxidative stress: total oxidative capacity, peroxide activity, LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM, oLAb (IgG)
timeFrame: up to 216 hrs after the first xenon-application
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen, Department for Anesthesia
state: North-Rhine Westfalia
Study officials:
affiliation: University Hospital RWTH Aachen, Department for Anesthesia
name: Rolf Rossaint, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References: