Inhalation of xenon-gas: Time it takes for the body to eliminate xenon after inhalation and the effect of xenon on Erythropoetin-levels in the blood of healthy volunteers.

Xenon-inhalation: elimination of xenon and its effect on erythropoetin-levels in blood of healthy volunteers - XEPO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000973-38-DE

Enrollment

144

Registered

2014-03-31

Start date

2014-05-14

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Trade Name: Xenon pro Anaesthesia 100 % (v/v) Pharmaceutical Form: Inhalation solution INN or Proposed INN: XENON (133XE) CAS Number: 14932-42-4 Concentration unit: % percent Concentration type: range

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male subjects, age >18 years, legally competent to sign, without any known medical condition or medication prescribed at the Uniklinik RWTH Aachen Persons that are able and willing to understand and follow the instructions of the study personnel. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 hypersensivity 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
Main Objective: To analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation. ;Secondary Objective: First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spektroskopy. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growht factors (Hypoxia inducible factor (HIF)1a, Fibroblast Growth Factors (FGFs), Hepatocyte Growth Factor (HGF), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), IL-8, VEGF, MIF and SDF-1a) Oxidative stress: total oxidative capacity (TOC), peroxide activity (EPA assay), LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM or oLAb (IgG) or even both of them) ;Primary end point(s): Comparison of erythropoetin-levels in blood of healthy volunteers directly after xenon-application and during > 120 h. ;Timepoint(s) of evaluation of this end point: during > 120 h after xenon-application	—

Measure

Time frame

Main Objective: To analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation. ;Secondary Objective: First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spektroskopy. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growht factors (Hypoxia inducible factor (HIF)1a, Fibroblast Growth Factors (FGFs), Hepatocyte Growth Factor (HGF), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), IL-8, VEGF, MIF and SDF-1a) Oxidative stress: total oxidative capacity (TOC), peroxide activity (EPA assay), LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM or oLAb (IgG) or even both of them) ;Primary end point(s): Comparison of erythropoetin-levels in blood of healthy volunteers directly after xenon-application and during > 120 h. ;Timepoint(s) of evaluation of this end point: during > 120 h after xenon-application

—

Secondary

Measure	Time frame
Secondary end point(s): First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spektroskopy. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growht factors (Hypoxia inducible factor (HIF)1a, Fibroblast Growth Factors (FGFs), Hepatocyte Growth Factor (HGF), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), IL-8, VEGF, MIF and SDF-1a) Oxidative stress: total oxidative capacity (TOC), peroxide activity (EPA assay), LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM or oLAb (IgG) or even both of them) ;Timepoint(s) of evaluation of this end point: Before each inhalation Directely after the first inhalation 2 h after the first inhalation 4 h after the first inhalation 8 h after the first inhalation 22-24 h after each inhalation 46-48 h after each inhalation 70-72 h after the last inhalation 94-96 h after the last inhalation 118-120 h after the last inhalation	—

Measure

Time frame

Secondary end point(s): First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spektroskopy. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growht factors (Hypoxia inducible factor (HIF)1a, Fibroblast Growth Factors (FGFs), Hepatocyte Growth Factor (HGF), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), IL-8, VEGF, MIF and SDF-1a) Oxidative stress: total oxidative capacity (TOC), peroxide activity (EPA assay), LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM or oLAb (IgG) or even both of them) ;Timepoint(s) of evaluation of this end point: Before each inhalation Directely after the first inhalation 2 h after the first inhalation 4 h after the first inhalation 8 h after the first inhalation 22-24 h after each inhalation 46-48 h after each inhalation 70-72 h after the last inhalation 94-96 h after the last inhalation 118-120 h after the last inhalation

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Countries

Germany

Contacts

Public ContactProject Management

Clinical Trial Center Aachen

asudhoff@ukaachen.de+492418037429

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026