The Role of Ninjurin-1 During Systemic Inflammation (Ninj1)

September 1, 2014 updated by: Dr. Patrick Meybohm, M.D.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
        • Department of Anesthesiology, University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SIRS patients: Intensive care unit

Description

Inclusion Criteria:

  • age > 18 years
  • cardiac surgery patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ninj1 expression on blood leukocytes
Time Frame: one day post surgery
one day post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one day post surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one day post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Patrick Meybohm, M.D.

Investigators

  • Principal Investigator: Patrick Meybohm, MD, Department of Anesthesiology, University Hospital Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

September 1, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NINJ1-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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