Validation of the Percentage of Alveolar Fibrocyte as Biomarker During ARDS

NCT01854424 | Completed

• 2 other identifiers: NI11026AOM 11005
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and associated with outcome in different diseases. In previous study, we have demonstrated the presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their association with patient outcome. The purpose of this multicentric observational prospective study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS (survivors vs. non survivors) and to confirm their association with 28-day mortality.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Mechanical Ventilation

Keywords

Fibrocyte; Acute Respiratory Distress Syndrome; Serum Amyloid P; Fibrosis; Mortality

Outcome Measures

Primary Outcomes (1)

• To determine the percentage of alveolar fibrocytes in survivors vs. non survivors during ARDS

  Association with 28-day mortality after inclusion

  alveolar fibrocytes percentage in BALF obtained in the 48 hours following ARDS diagnosis

Secondary Outcomes (3)

• To evaluate kinetics of alveolar and circulating fibrocytes between day-1 and day-14 of ARDS evolution

  < day-2, day-3, day 5-7, day 10-14

• To test the prognostic value of the percentage of alveolar fibrocytes during ARDS

  < day-2

• To evaluate the association between the percentage of alveolar fibrocyte and inflammatory and fibroproliferative markers

  < day-2, day 5-7, day 10-14

Study Arms (1)

ARDS

Ventilated patients with ARDS criteria (Berlin criteria) will be recruited in 3 ICU (2 from Bichat Hospital and 1 from Tenon Hospital, Paris) during the first 48 hours of their evolution. The patients will considered in 2 groups during analysis by taking into account their vital status at day-28 of inclusion.

Other: Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.

Interventions

Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution. OTHER

All the samples will be obtained during current care in the first week of evolution, and the last set of samples (BAL and blood sample between day 10-14) only in patients still under ventilation at this time point.

ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically Ventilated patients after Sepsis, infectious pneumonia, trauma or postoperative complications.

You may qualify if:

• Ventilated patients with ARDS criteria as defined by Berlin criteria during the first 48 hours of evolution.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital TENON, département d'anesthésie-réanimation

Paris, 75970, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients or relatives will be informed of the study. The samples (Bronchoalveolar lavage fluid -BALF-and blood samples) will be obtained in current care and stored in an authorized center of biological resources (CRB Bichat- DC 2009-940)

MeSH Terms

Conditions

Respiratory Distress Syndrome; Fibrosis

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Christophe Quesnel, MD, PhD

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 11, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

FR (1)