Multi Marker Approach Interest in Emergency in Acute Resp... | NCT00835809

Studies
Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic

NCT00835809

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Sep 8, 2010Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Acute Respiratory Insufficiency

Interventions

Not provided

Countries

France

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

ID	Type	Description	Link
2008-A00703-52	Registry Identifier	ID RCB

Status Module

Record Verification Date

Sep 2010

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

Oct 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Feb 3, 2009

First Submission Date that Met QC Criteria

Feb 3, 2009

First Posted Date

Feb 4, 2009Estimated

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 6, 2010

Last Update Posted Date

Sep 8, 2010Estimated

Name	Class
Regional Clinical Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.

We propose to determine the more relevant marker combination in this case.

Detailed Description

In urgence of a severe acute respiratory insufficiency,for thanks to an approach diagnostic, therapeutic and prognostic we propose to determine the more relevant biomarker combination.

An expert committee will compare the biomarker diagnostic and prognostic relevance thanks to all elements clinico-biological and patient monitoring.

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

Retention

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute respiratory diseases.		Patient admit in emergency or intensive care unite with acute respiratory insufficiency.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Oxygen saturation below or equal to 92% in ambient air.
Respiratory frequence above 25 cycle per minute

Exclusion Criteria:

Minors
Pregnant or lactating women
Patient without social security
Patient hospitalize without consent
Chest pain with acute coronary electro-cardiographic change leading immediate achievement of a diagnostic coronary angiography and/or therapeutic
Pneumothorax

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

Emergency and unit intensive care patient.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ARA SOMOHANO Claire, PH	Emergency NGO Onlus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Grenoble		Grenoble	Grenoble	38000	France

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided