Influence on Erythropoetin-level by Xenon (XEPO)

March 30, 2015 updated by: RWTH Aachen University

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North-Rhine Westfalia
      • Aachen, North-Rhine Westfalia, Germany, 52074
        • University Hospital RWTH Aachen, Department for Anesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 216 hrs after first xenon-application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 216 hrs after the first xenon-application

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 216 hrs after the first xenon-application
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
up to 216 hrs after the first xenon-application
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
up to 216 hrs after the first xenon-application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Rolf Rossaint, Prof. M.D., University Hospital RWTH Aachen, Department for Anesthesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-026
  • 2014-000973-38 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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