Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome

NCT ID: NCT00440882

Last Updated: 2008-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Brief Summary

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Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.

The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.

Detailed Description

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Primary outcome: To analyse the changes of Transforming Growth Factor b1 and Procollagen III during the acute respiratory distress syndrome.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ARDS with a PaO2/FIO2 \< 200 mmHg at a positive end-expiratory pressure (PEEP) ³ 5 cm H2O
* ARDS criteria from less than 24 hours
* Informed consent

Exclusion Criteria

* Pregnancy
* Chronic interstitial or fibrosis lung diseases
* Hepatic chronic disease
* Neutropenia £1 G/l
* Corticosteroid (more than 200 mg/day of hydrocortisone or equivalent, less than 2 weeks before inclusion)
* Immunosuppressive therapy within the last 30 days
* Participation in any investigational drug or devices study within 30 days prior study entry
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Assistance Publique Hopitaux De Marseille

Principal Investigators

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Jean-Marie FOREL, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HM

Locations

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Hopital Sainte Marguerite

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2004/16

Identifier Type: -

Identifier Source: org_study_id