healthy volunteers helium induced organ protection
Conditions
Interventions
Trade Name: Heliox21
Product Name: Heliox21
Pharmaceutical Form: Modified-release granules
CAS Number: 7440597
Other descriptive name: HELIUM
Pharmaceutical form of the placebo: Inhalation gas
Route o
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers aged 18-65 years, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: alcohol consumption, untreated arterial hypertension, known renal impairment, liver disease, cardiovascular disease (arterial hypertension, angina, previous myocardial infarction, history of stroke), history of diabetes mellitus, coagulatopathy (PTT > 1.5 times control), anti coagulation drugs, antihypertensive drugs, known hypersensitivity, intolerance to any used substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether inhalation of helium induces early or late preconditioning in human endothelium ;Secondary Objective: measurement of endothelial adhesion molecules on leukocytes;Primary end point(s): The present application of helium seeks to investigate the possibility to precondition human endothelium with helium. This will be done by measurement of forearm blood flow using the venous occlusion plethysmography model. Primary end-point is blood flow and reactive hyperemia before and after ischemia reperfusion after stimulation with either serotonin as an endothelium-dependent vasodilator or sodium nitroprusside as an endothelium-independent vasodilator | — |
Countries
Netherlands
Outcome results
None listed