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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000973-38 | EudraCT Number |
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The analysis of the blood samples was much expensive than calculated. The recruitment had to be stopped after 36 study participants.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10min Xenon 15%, FiO2 75% | Experimental | 10 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
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| 10min Xenon 30%, FiO2 60% | Experimental | 10 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
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| 30min Xenon 15%, FiO2 75% | Experimental | 30 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
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| 30min Xenon 30%, FiO2 60% | Experimental | 30 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
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| 45min Xenon 15%, FiO2 75% | Experimental | 45 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
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| 45min Xenon 30%, FiO2 60% | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon pro Anaesthesia 100 % (V/V) | Drug | Xenon-gas inhalation of indicated concentrations during indicated time |
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| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Rossaint, Prof. M.D. | University Hospital RWTH Aachen, Department for Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital RWTH Aachen, Department for Anesthesia | Aachen | North-Rhine Westfalia | 52074 | Germany |
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45 minutes of 30 % xenon-inhalation (with 60 % FiO2)
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| 90min Xenon 15%, FiO2 75% | Experimental | 90 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
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| 90min Xenon 30%, FiO2 60% | Experimental | 90 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
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| 10min air medicinalis, FiO2 75% | Placebo Comparator | 10 minutes of air medicinalis (with 75 % FiO2) |
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| 10min air medicinalis, FiO2 60% | Placebo Comparator | 10 minutes of air medicinalis inhalation (with 60 % FiO2) |
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| 30min air medicinalis, FiO2 75% | Placebo Comparator | 30 minutes of air medicinalis inhalation (with 75 % FiO2) |
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| 30min air medicinalis, FiO2 60% | Placebo Comparator | 30 minutes of air medicinalis inhalation (with 60 % FiO2) |
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| 45min air medicinalis, FiO2 75% | Placebo Comparator | 45 minutes of air medicinalis inhalation (with 75 % FiO2) |
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| 45min air medicinalis, FiO2 60% | Placebo Comparator | 45 minutes of air medicinalis inhalation (with 60 % FiO2) |
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| 90min air medicinalis, FiO2 75% | Placebo Comparator | 90 minutes of air medicinalis inhalation (with 75 % FiO2) |
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| 90min air medicinalis, FiO2 60% | Placebo Comparator | 90 minutes of air medicinalis inhalation (with 60 % FiO2) |
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| Aer medicinalis Linde 100% | Drug |
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| up to 216 hrs after the first xenon-application |
| 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) | 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 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 |