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

October 8, 2008 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Hôpital Sainte Marguerite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Jean-Marie FOREL, MD, AP-HM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

October 9, 2008

Last Update Submitted That Met QC Criteria

October 8, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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