Influence on Erythropoetin-level by Xenon (XEPO)

RWTH Aachen University

Status and phase: Terminated; Phase 3

Conditions: Healthy Volunteers

Treatments: Drug: Aer medicinalis Linde 100%; Drug: Xenon pro Anaesthesia 100 % (V/V)

Study type: Interventional

Funder types: Other

Identifiers

NCT02129400

14-026

2014-000973-38 (EudraCT Number)

Details and patient eligibility

About

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 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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 16 patient groups, including a placebo group

10min Xenon 15%, FiO2 75%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

10min Xenon 30%, FiO2 60%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

30min Xenon 15%, FiO2 75%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

30min Xenon 30%, FiO2 60%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

45min Xenon 15%, FiO2 75%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

45min Xenon 30%, FiO2 60%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

90min Xenon 15%, FiO2 75%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

90min Xenon 30%, FiO2 60%

Experimental group

Description:

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

Treatment:

Drug: Xenon pro Anaesthesia 100 % (V/V)

10min air medicinalis, FiO2 75%

Placebo Comparator group

Description:

10 minutes of air medicinalis (with 75 % FiO2)

Treatment:

Drug: Aer medicinalis Linde 100%

10min air medicinalis, FiO2 60%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%

30min air medicinalis, FiO2 75%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%

30min air medicinalis, FiO2 60%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%

45min air medicinalis, FiO2 75%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%

45min air medicinalis, FiO2 60%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%

90min air medicinalis, FiO2 75%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%

90min air medicinalis, FiO2 60%

Placebo Comparator group

Description:

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

Treatment:

Drug: Aer medicinalis Linde 100%