Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
10min Xenon 15%, FiO2 75%
10 minutes of 15 % xenon-inhalation (with 75 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
10min Xenon 30%, FiO2 60%
10 minutes of 30 % xenon-inhalation (with 60 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
30min Xenon 15%, FiO2 75%
30 minutes of 15 % xenon-inhalation (with 75 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
30min Xenon 30%, FiO2 60%
30 minutes of 30 % xenon-inhalation (with 60 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
45min Xenon 15%, FiO2 75%
45 minutes of 15 % xenon-inhalation (with 75 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
45min Xenon 30%, FiO2 60%
45 minutes of 30 % xenon-inhalation (with 60 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
90min Xenon 15%, FiO2 75%
90 minutes of 15 % xenon-inhalation (with 75 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
90min Xenon 30%, FiO2 60%
90 minutes of 30 % xenon-inhalation (with 60 % FiO2)
干预措施: Xenon pro Anaesthesia 100 % (V/V) (Drug)
10min air medicinalis, FiO2 75%
10 minutes of air medicinalis (with 75 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
10min air medicinalis, FiO2 60%
10 minutes of air medicinalis inhalation (with 60 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
30min air medicinalis, FiO2 75%
30 minutes of air medicinalis inhalation (with 75 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
30min air medicinalis, FiO2 60%
30 minutes of air medicinalis inhalation (with 60 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
45min air medicinalis, FiO2 75%
45 minutes of air medicinalis inhalation (with 75 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
45min air medicinalis, FiO2 60%
45 minutes of air medicinalis inhalation (with 60 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
90min air medicinalis, FiO2 75%
90 minutes of air medicinalis inhalation (with 75 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
90min air medicinalis, FiO2 60%
90 minutes of air medicinalis inhalation (with 60 % FiO2)
干预措施: Aer medicinalis Linde 100% (Drug)
结局指标
主要结局
Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total
时间窗: 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
次要结局
- 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)