Influence on Erythropoetin-level by Xenon

Overview

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

Full Title of Study: “Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2015

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

  • Drug: Xenon pro Anaesthesia 100 % (V/V)
    • Xenon-gas inhalation of indicated concentrations during indicated time
  • Drug: Aer medicinalis Linde 100%

Arms, Groups and Cohorts

  • Experimental: 10min Xenon 15%, FiO2 75%
    • 10 minutes of 15 % xenon-inhalation (with 75 % FiO2)
  • Experimental: 10min Xenon 30%, FiO2 60%
    • 10 minutes of 30 % xenon-inhalation (with 60 % FiO2)
  • Experimental: 30min Xenon 15%, FiO2 75%
    • 30 minutes of 15 % xenon-inhalation (with 75 % FiO2)
  • Experimental: 30min Xenon 30%, FiO2 60%
    • 30 minutes of 30 % xenon-inhalation (with 60 % FiO2)
  • Experimental: 45min Xenon 15%, FiO2 75%
    • 45 minutes of 15 % xenon-inhalation (with 75 % FiO2)
  • Experimental: 45min Xenon 30%, FiO2 60%
    • 45 minutes of 30 % xenon-inhalation (with 60 % FiO2)
  • Experimental: 90min Xenon 15%, FiO2 75%
    • 90 minutes of 15 % xenon-inhalation (with 75 % FiO2)
  • Experimental: 90min Xenon 30%, FiO2 60%
    • 90 minutes of 30 % xenon-inhalation (with 60 % FiO2)
  • Placebo Comparator: 10min air medicinalis, FiO2 75%
    • 10 minutes of air medicinalis (with 75 % FiO2)
  • Placebo Comparator: 10min air medicinalis, FiO2 60%
    • 10 minutes of air medicinalis inhalation (with 60 % FiO2)
  • Placebo Comparator: 30min air medicinalis, FiO2 75%
    • 30 minutes of air medicinalis inhalation (with 75 % FiO2)
  • Placebo Comparator: 30min air medicinalis, FiO2 60%
    • 30 minutes of air medicinalis inhalation (with 60 % FiO2)
  • Placebo Comparator: 45min air medicinalis, FiO2 75%
    • 45 minutes of air medicinalis inhalation (with 75 % FiO2)
  • Placebo Comparator: 45min air medicinalis, FiO2 60%
    • 45 minutes of air medicinalis inhalation (with 60 % FiO2)
  • Placebo Comparator: 90min air medicinalis, FiO2 75%
    • 90 minutes of air medicinalis inhalation (with 75 % FiO2)
  • Placebo Comparator: 90min air medicinalis, FiO2 60%
    • 90 minutes of air medicinalis inhalation (with 60 % FiO2)

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total
    • Time Frame: 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 Measures

  • First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rolf Rossaint, Prof. M.D., Principal Investigator, University Hospital RWTH Aachen, Department for Anesthesia

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