Ischemia-reperfusion InjuryIROX-NHNCT01486212
Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
An observational study of Ischemia-reperfusion Injury, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their structure can react with other molecules resulting in cell damage. This damage is due to several mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischemia-reperfusion Injury
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Dec 2011
- Phase
- Observational
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers. Male aged 18-40 years. Non smokers. No known history of familiar cardio/vascular diseases. No intake of prescription medicine.
Who may be able to join
- Male
- Between 18 and 40 years.
- Non smokers.
- No known history of familiar cardio/vascular diseases.
- No intake of prescription medicine.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their structure can react with other molecules resulting in cell damage. This damage is due to several mechanisms.
This is e.g what happens when human tissue is cut of from blood supply for a time, and the blood supply is again restored. The damage following the restoration of blood is known as "ischemia-reperfusion injury". The reopening of the vessels and thereby supplying oxygenated blood to the deprived tissue can in it self contribute to cell death due to excessive amounts of free radicals. Antioxidants can neutralize free radicals and thereby minimize their damage.
Read more
The purpose of the investigators methodology study is to make an ischemia-reperfusion model on healthy volunteers (on the lower limb) to examine the expression of markers that are expressed in the muscle and the blood when blood supply is cut of to an area and later restored. The investigators wish to measure the product of the damage caused by free radicals and the levels of antioxidants.
If the investigators can produce elevation of oxidative and inflammatory markers, this model can be used to test antioxidative intervention.
- Conditions
- Ischemia-reperfusion Injury
- Keywords
- Ischemia-reperfusion injury, Oxidative markers, Inflammatory markers
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers. | Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (MDA) in muscle.
Malondialdehyde (MDA), is a direct product of the lipidperoxidation occuring during reperfusion. It is caused by damage done by the free radicals.
Measured: A change from baseline to 30 minutes after ischemia.
Secondary outcomes (4)
Malondialdehyde (MDA) in blood
Measured: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Vitamin C
Vitamin C is an antioxidant.
Measured: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
YKL-40
YKL-40 is a marker that become elevated if local inflammation occurs.
Measured: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Cytokines (Interleukin 1β,4,6,10 og TNF-α)
Interleukin (IL)- 1β, IL-6 og TNF-α are pro-inflammatory markers. IL-4 og IL-10 are anti-inflammatory markers.
Measured: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-reperfusion InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Løvland Halladin, Herlev Hospital
- Investigators
- Natalie Halladin, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486212
- Sponsor's protocol ID
- IROX-NH
- Acronym
- IROX-NH
- Status last verified
- Dec 2012
- First submitted
- 17 Nov 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemia-reperfusion Injury Model on Healthy Volunteers and Measurement of Oxidative and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT01486212
- Acronym / sponsor ID
- IROX-NH / IROX-NH
- Conditions
- Ischemia-reperfusion Injury
- Keywords
- Ischemia-reperfusion injury, Oxidative markers, Inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Dec 2011 (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.
Oxygen is necessary for the survival of oxygen consuming organisms. But the organisms metabolism alter the oxygen to free radicals. Free radicals are molecules which due to their structure can react with other molecules resulting in cell damage. This damage is due to several mechanisms.
This is e.g what happens when human tissue is cut of from blood supply for a time, and the blood supply is again restored. The damage following the restoration of blood is known as "ischemia-reperfusion injury". The reopening of the vessels and thereby supplying oxygenated blood to the deprived tissue can in it self contribute to cell death due to excessive amounts of free radicals. Antioxidants can neutralize free radicals and thereby minimize their damage.
The purpose of the investigators methodology study is to make an ischemia-reperfusion model on healthy volunteers (on the lower limb) to examine the expression of markers that are expressed in the muscle and the blood when blood supply is cut of to an area and later restored. The investigators wish to measure the product of the damage caused by free radicals and the levels of antioxidants.
If the investigators can produce elevation of oxidative and inflammatory markers, this model can be used to test antioxidative intervention.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers. | – | –Male aged 18-40 years. Non-smokers. No known familiar disposition to vascular/heart diseases. No intake of prescription medicine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers. Male aged 18-40 years. Non smokers. No known history of familiar cardio/vascular diseases. No intake of prescription medicine.
Key inclusion criteria (5 listed)
- Male
- Between 18 and 40 years.
- Non smokers.
- No known history of familiar cardio/vascular diseases.
- No intake of prescription medicine.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malondialdehyde (MDA) in muscle.
Time frame: A change from baseline to 30 minutes after ischemia.
Malondialdehyde (MDA), is a direct product of the lipidperoxidation occuring during reperfusion. It is caused by damage done by the free radicals.
4 secondary outcomes
Malondialdehyde (MDA) in blood
Time frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Vitamin C
Time frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
YKL-40
Time frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
Cytokines (Interleukin 1β,4,6,10 og TNF-α)
Time frame: A change from baseline measured in blood to 5, 15, 30, 60 and 90 minutes after reperfusion.
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 12 Dec 2012.
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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.
Natalie Halladin, MD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia-reperfusion Injury, run by Herlev 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 5 inclusion and 0 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 12 Dec 2012. 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. 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?
Malondialdehyde (MDA) in muscle. (time frame: A change from baseline to 30 minutes after ischemia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2012.