Ninj1 ExpressionNinj1NCT02079597
The Role of Ninjurin-1 During Systemic Inflammation
An observational study of Ninj1 Expression and SIRS, run by Dr. Patrick Meybohm, M.D. at 1 site in Germany.
Trial summary
With the underlying study the investigators address the question if Ninjurin-1 (Ninj1) expression is altered in patients with systemic inflammatory response syndrome (SIRS) in comparison to healthy volunteers. The adhesion molecule Ninj1 is induced following nerve injury where it contributes to nerve generation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ninj1 Expression, SIRS
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Sep 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: SIRS patients: Intensive care unit
Who may be able to join
- age > 18 years
- cardiac surgery patients
Who cannot join
- included in an interventional study
- Preoperative Infection (e.g. Endocarditis)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Hospital Frankfurt
Frankfurt am Main, Hesse, 60596
About this study
Official title: Prospective Study to Analyze Ninjurin-1 and Its Soluble Part During Systemic Inflammation
- With the underlying study the investigators address the question if Ninjurin-1 (Ninj1) expression is altered in patients with systemic inflammatory response syndrome (SIRS) in comparison to healthy volunteers.
- The adhesion molecule Ninj1 is induced following nerve injury where it contributes to nerve generation. Besides it is described to facilitate leukocyte migration especially in the nervous system.
- The investigators hypothesize that Ninj1 expression is increased in SIRS patients, which will fortify its impact during inflammation and the transferability from bench to bedside.
- Conditions
- Ninj1 Expression, SIRS
- Keywords
- SIRS, Ninj1, Sepsis, Healthy
- Medical subject headings
- Sepsis
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 | Healthy individuals no infection | |
| SIRS | SIRS patients no included in an interventional study no peroperative infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ninj1 expression on blood leukocytes
Measured: one day post surgery
Secondary outcomes (1)
grade of systemic inflammation
routine inflammatory markers will be used to evaluate the grade of inflammation e.g. procalcitonin (PCT) Interleukin 6, lipopolysaccharide (LPS) binding protein (LBP). Retrospective evaluation for sepsis (bacterial infection)
Measured: one day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ninj1 ExpressionStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Patrick Meybohm, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital
- Investigators
- Patrick Meybohm, MD, Principal investigator, Department of Anesthesiology, University Hospital Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079597
- Sponsor's protocol ID
- NINJ1-001
- Acronym
- Ninj1
- Status last verified
- Sep 2014
- First submitted
- 4 Mar 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Analyze Ninjurin-1 and Its Soluble Part During Systemic Inflammation
- ClinicalTrials.gov ID
- NCT02079597
- Acronym / sponsor ID
- Ninj1 / NINJ1-001
- Conditions
- Ninj1 Expression, SIRS
- Keywords
- SIRS, Ninj1, Sepsis, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Patrick Meybohm, M.D.University, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Mar 2014 (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.
- With the underlying study the investigators address the question if Ninjurin-1 (Ninj1) expression is altered in patients with systemic inflammatory response syndrome (SIRS) in comparison to healthy volunteers.
- The adhesion molecule Ninj1 is induced following nerve injury where it contributes to nerve generation. Besides it is described to facilitate leukocyte migration especially in the nervous system.
- The investigators hypothesize that Ninj1 expression is increased in SIRS patients, which will fortify its impact during inflammation and the transferability from bench to bedside.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy individuals no infection |
| SIRS | – | –SIRS patients no included in an interventional study no peroperative infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SIRS patients: Intensive care unit
Key inclusion criteria (2 listed)
- age > 18 years
- cardiac surgery patients
Key exclusion criteria (2 listed)
- included in an interventional study
- Preoperative Infection (e.g. Endocarditis)
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
Ninj1 expression on blood leukocytes
Time frame: one day post surgery
1 secondary outcome
grade of systemic inflammation
Time frame: one day post surgery
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 3 Sep 2014.
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.
Patrick Meybohm, MD principal investigator
Department of Anesthesiology, University Hospital Frankfurt
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 Ninj1 Expression and SIRS, run by Dr. Patrick Meybohm, M.D. at 1 site in Germany.
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 2 inclusion and 2 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 3 Sep 2014. 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 Germany. 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?
Ninj1 expression on blood leukocytes (time frame: one day post surgery). 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 3 Sep 2014.