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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440882
First Posted: February 27, 2007
Last Update Posted: October 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique Hopitaux De Marseille
  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

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

Resource links provided by NLM:


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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Dr FOREL JM, Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00440882     History of Changes
Other Study ID Numbers: 2004/16
First Submitted: February 26, 2007
First Posted: February 27, 2007
Last Update Posted: October 9, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Mitogens
Complement Factor B
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs