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Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome (ARDS) Definition

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome Definition in Intensive Care Unit

Clinical Trial Summary

The ARDS has a clinical definition with criteria of the American-European Consensus Conference (1994). This definition inconveniently applies to a lot of patients with acute respiratory failure.

We know that there are 2 forms of ARDS morphology on CT scan : "lobar attenuation" (loss of aeration with no concomitant excess in lung tissue) predominating in the lower lobes and "non lobar attenuation" with diffuse and massive loss of aeration with excess lung tissue in all the pulmonary parenchyma.

Today, plasmatic biomarkers are used as prognostic and diagnostic markers of ARDS. Some of them are characteristics of the different damages in the ARDS (alveolar epithelium and vascular endothelium lesions) : sRAGE, SP-D, PAI 1 and sICAM 1.

This study's hypothesis is that patients with ARDS criteria and lobar morphology on CT scan present loss of aeration but no inflammatory pulmonary oedema, whereas patients with non lobar morphology on CT scan present both characteristics.

The primary purpose of our protocol is to show that the patients who respond to ARDS criteria and have a lobar morphology on CT scan do not have an elevation of the biomarkers specific to the pulmonary aggression of ARDS.

Clinical Trial Description

This multicentric prospective observational study will compare the level of different biomarkers specific to ARDS damages : the soluble form of the receptor for advanced glycation end products (sRAGE), the surfactant protein D (SP-D), Plasminogen Activator Inhibitor type 1 (PAI-1) and Soluble Intercellular Adhesion Molecule-1 (sICAM 1) in the two pulmonary morphologies of ARDS on CT scan : lobar and non lobar.

Patients under mechanical ventilation and with ARDS criteria for less than 24 hours(American-European Consensus Conference, 1994) will be enrolled.

Within 24 hours of enrolment, 10ml of blood sample will be collected and stored at -80°C. Plasmatic biomarker concentrations will be determined through ELISA method.

Within 48 hours of enrolment, patients will have a pulmonary CT scan without injection (end of expiration and ZEEP), a classical practice in this pathology.

Nine university hospitals will take part in this study. ;

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome
Clinical Trial Details
NCT number NCT01161901
Study type Observational
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase N/A
Start date June 2010
Completion date November 2011
View Details
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