NCT00440882

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

October 9, 2008

Status Verified

October 1, 2008

First QC Date

February 26, 2007

Last Update Submit

October 8, 2008

Conditions

Acute Respiratory Distress Syndrome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Chronic interstitial or fibrosis lung diseases
  • Hepatic chronic disease
  • Neutropenia £1 G/l
  • Immunosuppressive therapy within the last 30 days
  • Participation in any investigational drug or devices study within 30 days prior study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Sainte Marguerite

Marseille, 13009, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jean-Marie FOREL, MD

    AP-HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

September 1, 2004

Last Updated

October 9, 2008

Record last verified: 2008-10

Locations

FR(1)