Endothelial Dysfunction
Conditions
Keywords
Oxidative stress, Nitrogen oxide, Reactive oxygen species
Brief summary
The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is much higher than previously assumed, with approximately 10 % of patients undergoing non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study furthermore showed that patients treated with a high inspiratory oxygen fraction during surgery had a higher 1 year mortality compared with patients treated with a low inspiratory fraction. This was especially significant among patients undergoing cancer surgery. A possible explanation, is that a high oxygen fraction results in oxidative stress and endothelial dysfunction. With this randomized cross-over study we wish to investigate the effect of a high inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The primary outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a measure for the effect of oxygen on the autonomic nervous system.
Interventions
OTHER80% oxygen
OTHER30% oxygen
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent
Exclusion criteria
* Smoking, or ex-smoker Any kind of medication on a daily basis History of atopic dermatitis Known familiar hypercholesterolemia History of arteriosclerotic disease in the first and second-degree relatives Known or unknown arrhythmias, as measured by the baseline HRV-recording
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial dysfunction assessed by the EndoPat-system | After 2 hours of preoxygenation | Changes in baseline pulse-wave-amplitude (PWA) after ischemia-reperfusion from the baseline PWA measurement until 5 minutes after ischemia as a measure of altered endothelial cell function caused by high inspiratory oxygen fractions |
Secondary
| Measure | Time frame |
|---|---|
| Plasma-Malondialdehyde (MDA) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Arginine/Asymmetric dimethylarginine(ADMA) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system | Baseline measure conducted from baseline until 20 minutes of pre oxygenation. Secondary measures is conducted 20 minutes before withdrawal of the oxygen |
| Plasma-Advanced oxidation protein products (AOPP) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Ascorbate/Dehydroascorbate (AA/DHA) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Tetrahydrobiopterin | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
Countries
Denmark
Outcome results
None listed