High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers

Endothelial Dysfunction Clinical Trial

Official title:

Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: a Randomized Controlled Cross-over Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342405
• Other study ID #: SJ-409
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: May 26, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University Hospital Koge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Other:
• 80% oxygen

• 30% oxygen

Locations

Country	Name	City	State
Denmark	UHKoge	Koge

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial dysfunction assessed by the EndoPat-system	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	After 2 hours of preoxygenation	No
Secondary	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	No
Secondary	Plasma-Malondialdehyde (MDA)		Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure	No
Secondary	Plasma-Arginine/Asymmetric dimethylarginine(ADMA)		Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure	No
Secondary	Plasma-Tetrahydrobiopterin		Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure	No
Secondary	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	No
Secondary	Plasma-Ascorbate/Dehydroascorbate (AA/DHA)		Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure	No