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NCT00440882 Clinical Trial

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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00440882
Other study ID # 2004/16
Secondary ID
Status Completed
Phase N/A
First received February 26, 2007
Last updated October 8, 2008
Start date September 2004

Study information
Verified date October 2008
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

Locations
Country Name City State
France Hopital Sainte Marguerite Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

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