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Influence on Erythropoetin-level by Xenon

NCT ID: NCT02129400

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Healthy Volunteers

Keywords

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Xenon-inhalation Erythropoetin Pharmakokinetic Pharmacodynamic Hemodynamic parameters Inflammatory parameters Growth factors Oxidative stress parameters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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10min Xenon 15%, FiO2 75%

10 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

10min Xenon 30%, FiO2 60%

10 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

30min Xenon 15%, FiO2 75%

30 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

30min Xenon 30%, FiO2 60%

30 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

45min Xenon 15%, FiO2 75%

45 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

45min Xenon 30%, FiO2 60%

45 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

90min Xenon 15%, FiO2 75%

90 minutes of 15 % xenon-inhalation (with 75 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

90min Xenon 30%, FiO2 60%

90 minutes of 30 % xenon-inhalation (with 60 % FiO2)

Group Type EXPERIMENTAL

Xenon pro Anaesthesia 100 % (V/V)

Intervention Type DRUG

Xenon-gas inhalation of indicated concentrations during indicated time

10min air medicinalis, FiO2 75%

10 minutes of air medicinalis (with 75 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

10min air medicinalis, FiO2 60%

10 minutes of air medicinalis inhalation (with 60 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

30min air medicinalis, FiO2 75%

30 minutes of air medicinalis inhalation (with 75 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

30min air medicinalis, FiO2 60%

30 minutes of air medicinalis inhalation (with 60 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

45min air medicinalis, FiO2 75%

45 minutes of air medicinalis inhalation (with 75 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

45min air medicinalis, FiO2 60%

45 minutes of air medicinalis inhalation (with 60 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

90min air medicinalis, FiO2 75%

90 minutes of air medicinalis inhalation (with 75 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

90min air medicinalis, FiO2 60%

90 minutes of air medicinalis inhalation (with 60 % FiO2)

Group Type PLACEBO_COMPARATOR

Aer medicinalis Linde 100%

Intervention Type DRUG

Interventions

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Xenon pro Anaesthesia 100 % (V/V)

Xenon-gas inhalation of indicated concentrations during indicated time

Intervention Type DRUG

Aer medicinalis Linde 100%

Intervention Type DRUG

Other Intervention Names

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licence number: 56582.00.00 Pharmakotherapeutic group: medical gas Licence number: 68885.00.00 ATC-Code: V03AN05

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Rossaint, Prof. M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital RWTH Aachen, Department for Anesthesia

Locations

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University Hospital RWTH Aachen, Department for Anesthesia

Aachen, North-Rhine Westfalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2014-000973-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14-026

Identifier Type: -

Identifier Source: org_study_id