The Role of Ninjurin-1 During Systemic Inflammation

SIRS Clinical Trial

— Ninj1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079597
• Other study ID #: NINJ1-001
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: September 1, 2014
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years

• cardiac surgery patients

Exclusion Criteria:

• included in an interventional study

• Preoperative Infection (e.g. Endocarditis)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ninj1 Expression
• SIRS

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Patrick Meybohm, M.D.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Soluble Ninj1 concentration/expression rates	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	No
Primary	Ninj1 expression on blood leukocytes		one day post surgery	No
Secondary	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)	one day post surgery	No