Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007260

Trial Description

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Title

Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers

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Trial Acronym

XEPO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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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Organizational Data

  •   DRKS00007260
  •   2016/03/03
  •   2014/04/15
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02129400  (ClinicalTrials.gov)
  •   2014-000973-38  (RWTH Aachen University)
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Health Condition or Problem studied

  •   Healthy Volunteers
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Interventions/Observational Groups

  •   Drug: Xenon pro Anaesthesia 100 % (V/V)
  •   Drug: Aer medicinalis Linde 100%
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- 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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/05/31
  •   96
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Inclusion Criteria

  •   Male
  •   18   Years
  •   65   Years
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Additional 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

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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

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Addresses

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    • RWTH Aachen University
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    • University Hospital RWTH Aachen, Department for Anesthesia
    • Rolf Rossaint, Prof. M.D. 
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    •   [---]*
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    • Rolf Rossaint, Prof. M.D. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.