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Completed

NCT Number: NCT02079597

The Role of Ninjurin-1 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.

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Key information

Conditions

Ninj1 Expression Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms SIRS Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, University Hospital Frankfurt

Frankfurt am Main, Hesse, 60596, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • cardiac surgery patients

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Ninj1 expression on blood leukocytes

    Time frame: one day post surgery

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dr. Patrick Meybohm, M.D.

Other

Registry information

Official study title

Prospective Study to Analyze Ninjurin-1 and Its Soluble Part During Systemic Inflammation

Acronym: Ninj1

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 6, 2014
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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