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Trial record 1 of 1 for:    NINJ1
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The Role of Ninjurin-1 During Systemic Inflammation (Ninj1)

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ClinicalTrials.gov Identifier: NCT02079597
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital

Brief 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. 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.

Condition or disease
Ninj1 Expression SIRS

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Study to Analyze Ninjurin-1 and Its Soluble Part During Systemic Inflammation
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Group/Cohort
Healthy
Healthy individuals no infection
SIRS
SIRS patients no included in an interventional study no peroperative infection



Primary Outcome Measures :
  1. Ninj1 expression on blood leukocytes [ Time Frame: one day post surgery ]

Secondary Outcome Measures :
  1. grade of systemic inflammation [ Time Frame: one day post surgery ]
    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)


Other Outcome Measures:
  1. Soluble Ninj1 concentration/expression rates [ Time Frame: one day post surgery ]
    Concentration will be measured in plasma samples as well as from whole blood culture incubated with 100 ng/ml lipopolysaccharide for 6, 16 and 24 h.


Biospecimen Retention:   Samples With DNA
whole blood, plasma, RNA and cDNA extracted from whole blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
SIRS patients: Intensive care unit
Criteria

Inclusion Criteria:

  • age > 18 years
  • cardiac surgery patients

Exclusion Criteria:

  • included in an interventional study
  • Preoperative Infection (e.g. Endocarditis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079597


Locations
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Germany
Department of Anesthesiology, University Hospital Frankfurt
Frankfurt, Hessen, Germany, 60596
Sponsors and Collaborators
Dr. Patrick Meybohm, M.D.
Investigators
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Principal Investigator: Patrick Meybohm, MD Department of Anesthesiology, University Hospital Frankfurt

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Responsible Party: Dr. Patrick Meybohm, M.D., PD Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02079597     History of Changes
Other Study ID Numbers: NINJ1-001
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014

Keywords provided by Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University Hospital:
SIRS
Ninj1
Sepsis
Healthy

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes