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Influence on Erythropoetin-level by Xenon (XEPO)

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ClinicalTrials.gov Identifier: NCT02129400
Recruitment Status : Terminated (The analysis of the blood samples was much expensive than calculated. The recruitment had to be stopped after 36 study participants.)
First Posted : May 2, 2014
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Xenon pro Anaesthesia 100 % (V/V) Drug: Aer medicinalis Linde 100% Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10min Xenon 15%, FiO2 75%
10 minutes of 15 % xenon-inhalation (with 75 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 10min Xenon 30%, FiO2 60%
10 minutes of 30 % xenon-inhalation (with 60 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 30min Xenon 15%, FiO2 75%
30 minutes of 15 % xenon-inhalation (with 75 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 30min Xenon 30%, FiO2 60%
30 minutes of 30 % xenon-inhalation (with 60 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 45min Xenon 15%, FiO2 75%
45 minutes of 15 % xenon-inhalation (with 75 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 45min Xenon 30%, FiO2 60%
45 minutes of 30 % xenon-inhalation (with 60 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 90min Xenon 15%, FiO2 75%
90 minutes of 15 % xenon-inhalation (with 75 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Experimental: 90min Xenon 30%, FiO2 60%
90 minutes of 30 % xenon-inhalation (with 60 % FiO2)
Drug: Xenon pro Anaesthesia 100 % (V/V)
Xenon-gas inhalation of indicated concentrations during indicated time
Other Name: licence number: 56582.00.00

Placebo Comparator: 10min air medicinalis, FiO2 75%
10 minutes of air medicinalis (with 75 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 10min air medicinalis, FiO2 60%
10 minutes of air medicinalis inhalation (with 60 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 30min air medicinalis, FiO2 75%
30 minutes of air medicinalis inhalation (with 75 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 30min air medicinalis, FiO2 60%
30 minutes of air medicinalis inhalation (with 60 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 45min air medicinalis, FiO2 75%
45 minutes of air medicinalis inhalation (with 75 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 45min air medicinalis, FiO2 60%
45 minutes of air medicinalis inhalation (with 60 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 90min air medicinalis, FiO2 75%
90 minutes of air medicinalis inhalation (with 75 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05

Placebo Comparator: 90min air medicinalis, FiO2 60%
90 minutes of air medicinalis inhalation (with 60 % FiO2)
Drug: Aer medicinalis Linde 100%
Other Names:
  • Pharmakotherapeutic group: medical gas
  • Licence number: 68885.00.00
  • ATC-Code: V03AN05




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Other Outcome Measures:
  1. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) [ Time Frame: 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


  2. Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growth factors (HIF1α, FGFs, HGF, MGFs, PDGF, VEGF, IL-8, VEGF, MIF, SDF-1a) [ 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


  3. Oxidative stress: total oxidative capacity, peroxide activity, LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM, oLAb (IgG) [ Time Frame: 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




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129400


Locations
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Germany
University Hospital RWTH Aachen, Department for Anesthesia
Aachen, North-Rhine Westfalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Rolf Rossaint, Prof. M.D. University Hospital RWTH Aachen, Department for Anesthesia

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02129400     History of Changes
Other Study ID Numbers: 14-026
2014-000973-38 ( EudraCT Number )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by RWTH Aachen University:
Xenon-inhalation
Erythropoetin
Pharmakokinetic
Pharmacodynamic
Hemodynamic parameters
Inflammatory parameters
Growth factors
Oxidative stress parameters

Additional relevant MeSH terms:
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Xenon
Epoetin Alfa
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hematinics