Endothelial DysfunctionNCT02342405
High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers
A study testing 80% oxygen and 30% oxygen in people with Endothelial Dysfunction, run by Zealand University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- 80% oxygen and 30% oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: a Randomized Controlled Cross-over Trial
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.
- Conditions
- Endothelial Dysfunction
- Being tested
- 80% oxygen, 30% oxygen
- Keywords
- Oxidative stress, Nitrogen oxide, Reactive oxygen species
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
80% oxygenOther
30% oxygenOther
| Study group | Role | What they receive |
|---|---|---|
| 30% oxygen | Placebo comparator | Inhalation of 30% oxygen Receives: Other: 30% oxygen |
| 80% oxygen | Experimental | Inhalation of 80% oxygen Receives: Other: 80% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Plasma-Arginine/Asymmetric dimethylarginine(ADMA)
Measured: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Plasma-Tetrahydrobiopterin
Measured: 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)
Measured: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Plasma-Ascorbate/Dehydroascorbate (AA/DHA)
Measured: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Gögenur, Zealand University Hospital
- Investigators
- Ismail Gögenur, MD, DMSc, Principal investigator, Department of surgery, Køge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342405
- Sponsor's protocol ID
- SJ-409
- Status last verified
- May 2015
- First submitted
- 14 Jan 2015
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28922226
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: a Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT02342405
- Acronym / sponsor ID
- SJ-409
- Conditions
- Endothelial Dysfunction
- Keywords
- Oxidative stress, Nitrogen oxide, Reactive oxygen species
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30% oxygen | Placebo comparator | Other: 30% oxygenInhalation of 30% oxygen |
| 80% oxygen | Experimental | Other: 80% oxygenInhalation of 80% oxygen |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 80% oxygen | Other | 80% oxygen |
| 30% oxygen | Other | 30% oxygen |
Primary outcome
Endothelial dysfunction assessed by the EndoPat-system
Time frame: 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
6 secondary outcomes
Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system
Time frame: 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)
Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Plasma-Arginine/Asymmetric dimethylarginine(ADMA)
Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Plasma-Tetrahydrobiopterin
Time frame: 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)
Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Plasma-Ascorbate/Dehydroascorbate (AA/DHA)
Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 28922226Larsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Gögenur, MD, DMSc principal investigator
Department of surgery, Køge University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 80% oxygen and 30% oxygen in people with Endothelial Dysfunction, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial dysfunction assessed by the EndoPat-system (time frame: After 2 hours of preoxygenation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.