NCT02079597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

March 4, 2014

Last Update Submit

September 1, 2014

Conditions

Ninj1 ExpressionSIRS

Keywords

SIRSNinj1SepsisHealthy

Outcome Measures

Primary Outcomes (1)

  • Ninj1 expression on blood leukocytes

    one day post surgery

Secondary Outcomes (1)

  • grade of systemic inflammation

    one day post surgery

Other Outcomes (1)

  • Soluble Ninj1 concentration/expression rates

    one day post surgery

Study Arms (2)

Healthy

Healthy individuals no infection

SIRS

SIRS patients no included in an interventional study no peroperative infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SIRS patients: Intensive care unit

You may qualify if:

  • age \> 18 years
  • cardiac surgery patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, University Hospital Frankfurt

Frankfurt am Main, Hesse, 60596, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, RNA and cDNA extracted from whole blood samples

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Meybohm, MD

    Department of Anesthesiology, University Hospital Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. Patrick Meybohm, M.D.

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

DE(1)