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

This study has been completed.

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00440882

Purpose

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.

Condition
Acute Respiratory Distress Syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	September 2004

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients whom suffered ARDS with a PaO2/FIO2 < 200 mmHg at a positive end-expiratory pressure (PEEP) ³ 5 cm H2O and for which ARDS criteria from less than 24 hours

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440882

Locations

France
Hopital Sainte Marguerite
Marseille, France, 13009

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:

Jean-Marie FOREL, MD

AP-HM

More Information

Responsible Party:	Assistance Publique Hopitaux De Marseille ( Dr FOREL JM )
Study ID Numbers:	2004/16
Study First Received:	February 26, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00440882
Health Authority:	France: Ministry of Health

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009