NCT02342405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

January 14, 2015

Last Update Submit

May 26, 2015

Conditions

Endothelial Dysfunction

Keywords

Oxidative stressNitrogen oxideReactive oxygen species

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 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-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

  • Plasma-Tetrahydrobiopterin

    Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

  • 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

  • +1 more secondary outcomes

Study Arms (2)

30% oxygen

PLACEBO COMPARATOR

Inhalation of 30% oxygen

Other: 30% oxygen

80% oxygen

EXPERIMENTAL

Inhalation of 80% oxygen

Other: 80% oxygen

Interventions

80% oxygenOTHER
80% oxygen
30% oxygenOTHER
30% oxygen

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHKoge

Køge, 4600, Denmark

Location

Related Publications (1)

  • Larsen MHH, Ekeloef S, Kokotovic D, Schou-Pedersen AM, Lykkesfeldt J, Gogenur I. Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: A Randomized Controlled Crossover Pilot Study. Anesth Analg. 2017 Nov;125(5):1793-1796. doi: 10.1213/ANE.0000000000002357.

    PMID: 28922226DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Ismail Gögenur, MD, DMSc

    Department of surgery, Køge University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor.

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

DK(1)