ischemia reperfusion injury MedDRA version: 9.1 Level: LLT Classification code 10023034 Term: Ischemia peripheral
Conditions
Interventions
Trade Name: Vitamin C-Injektopas 7,5 g-Injektionslösung
Product Name: vitamin C
Pharmaceutical Form: Injection*
INN or Proposed INN: ascorbic acid
Concentration unit: g gram(s)
Concentration number: 7
Sponsors
Universitätsklinik für klinische Pharmakologie, Medizinische Universität Wien
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Men aged between 18 and 45 years - Nonsmoker for more than 3 months - Body mass index between 18 and 25 kg/m2 - Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant 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: Any of the following will exclude a subject from the study: - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preciding the study - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug including over-the-counter drugs. - Symptoms of a clinically relevant illness in the 2 weeks before the first study day - History or presence of gastrointestinal, liver of kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug - Blood donation during the previous 3 weeks - History of hypersensitivity to parenteral vitamin C. - Glucose-6-phosphate dehydrogenase deficiency - Thalassemia, haemochromatosis - History of urolithiasis - Any magnetic or paramagnetic device not removable - Claustrophobia - Regular use of supplementary oral Vitamin C or Vitamin C containing substances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether mechanical post-conditioning prevents skeletal muscle IR injury. To study whether high concentrations of exogenous vitamin C prevent skeletal muscle IR injury. ;Secondary Objective: To provide data about the time course of high energy phosphate levels (ATP, phosphocreatine and inorganci phosphate) and pH in skeletal muscle tissue after the onset of ischemia and reperfusion. To determine systemic plasma concentrations of vitamin C and of markers of oxidative stress before and after 20 minutes of leg ischemia in the absence and presence of post-conditioning or vitamin C administration To determine the concentration of cellular proteins like NF-?B before and after the onset of ischemia ;Primary end point(s): - Change in cellular high energy phosphate levels and venous pH concentration | — |
Countries
Austria
Outcome results
None listed