Influence on Erythropoetin-level by Xenon
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Aer medicinalis Linde 100%
- Registration Number
- NCT02129400
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 36
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 90min Xenon 15%, FiO2 75% Xenon pro Anaesthesia 100 % (V/V) 90 minutes of 15 % xenon-inhalation (with 75 % FiO2) 10min Xenon 30%, FiO2 60% Xenon pro Anaesthesia 100 % (V/V) 10 minutes of 30 % xenon-inhalation (with 60 % FiO2) 30min Xenon 15%, FiO2 75% Xenon pro Anaesthesia 100 % (V/V) 30 minutes of 15 % xenon-inhalation (with 75 % FiO2) 45min Xenon 15%, FiO2 75% Xenon pro Anaesthesia 100 % (V/V) 45 minutes of 15 % xenon-inhalation (with 75 % FiO2) 90min Xenon 30%, FiO2 60% Xenon pro Anaesthesia 100 % (V/V) 90 minutes of 30 % xenon-inhalation (with 60 % FiO2) 10min air medicinalis, FiO2 75% Aer medicinalis Linde 100% 10 minutes of air medicinalis (with 75 % FiO2) 45min Xenon 30%, FiO2 60% Xenon pro Anaesthesia 100 % (V/V) 45 minutes of 30 % xenon-inhalation (with 60 % FiO2) 30min air medicinalis, FiO2 60% Aer medicinalis Linde 100% 30 minutes of air medicinalis inhalation (with 60 % FiO2) 45min air medicinalis, FiO2 75% Aer medicinalis Linde 100% 45 minutes of air medicinalis inhalation (with 75 % FiO2) 30min Xenon 30%, FiO2 60% Xenon pro Anaesthesia 100 % (V/V) 30 minutes of 30 % xenon-inhalation (with 60 % FiO2) 90min air medicinalis, FiO2 60% Aer medicinalis Linde 100% 90 minutes of air medicinalis inhalation (with 60 % FiO2) 10min Xenon 15%, FiO2 75% Xenon pro Anaesthesia 100 % (V/V) 10 minutes of 15 % xenon-inhalation (with 75 % FiO2) 10min air medicinalis, FiO2 60% Aer medicinalis Linde 100% 10 minutes of air medicinalis inhalation (with 60 % FiO2) 90min air medicinalis, FiO2 75% Aer medicinalis Linde 100% 90 minutes of air medicinalis inhalation (with 75 % FiO2) 30min air medicinalis, FiO2 75% Aer medicinalis Linde 100% 30 minutes of air medicinalis inhalation (with 75 % FiO2) 45min air medicinalis, FiO2 60% Aer medicinalis Linde 100% 45 minutes of air medicinalis inhalation (with 60 % FiO2)
- Primary Outcome Measures
Name Time Method Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total 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
Name Time Method First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy 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
Trial Locations
- Locations (1)
University Hospital RWTH Aachen, Department for Anesthesia
🇩🇪Aachen, North-Rhine Westfalia, Germany