IL 6 Measurement Using a New Densitometric Bedside (POC)... | NCT00525369

Studies
IL 6 Measurement Using a New Densitometric Bedside (POC) Test

NCT00525369

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Sep 5, 2007Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Sepsis, Septic Shock

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 2007

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 4, 2007

First Submission Date that Met QC Criteria

Sep 4, 2007

First Posted Date

Sep 5, 2007Estimated

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 4, 2007

Last Update Posted Date

Sep 5, 2007Estimated

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

In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis

Detailed Description

In an equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes) that allows IL-6 measurements at the bedside. We then compared the respective test results to those obtained with conventional ELISA analysis

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-90
Written informed consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans-Georg Schlosser, MD	Charite University, Berlin, Germany	Principal Investigator
Joerg C Schefold, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University Medicine Berlin		Berlin	State of Berlin	13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided