The Role of Ninjurin-1 During Systemic Inflammation | NCT02079597

Studies
The Role of Ninjurin-1 During Systemic Inflammation

NCT02079597

Sponsor

Dr. Patrick Meybohm, M.D.

Status

Completed

Last Update Posted

Sep 3, 2014Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Ninj1 Expression
SIRS

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2014

Last Update Posted Date

Sep 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Patrick Meybohm, M.D., PD Dr. Patrick Meybohm, M.D., Johann Wolfgang Goethe University HospitalSponsor-Investigator

Lead Sponsor

Dr. Patrick Meybohm, M.D.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Healthy individuals no infection
SIRS		SIRS patients no included in an interventional study no peroperative infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age > 18 years
cardiac surgery patients

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

SIRS patients: Intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Meybohm, MD	Department of Anesthesiology, University Hospital Frankfurt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, University Hospital Frankfurt		Frankfurt am Main	Hesse	60596	Germany

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

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Browse Branches

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