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

NCT01161901 | Completed

• 1 other identifier: CHU-0078
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Plasmatic biomarkers; Lung Morphology; Mechanical ventilation; CT scan

Outcome Measures

Primary Outcomes (1)

• Plasmatic concentrations of biomarkers specific to the pulmonary aggression of ARDS in the 2 different morphologies on CT scan (lobar and non lobar): • sRAGE • SP-D • sICAM 1 • PAI 1.

  within 24 hours of enrolment

Secondary Outcomes (1)

• Compare the 2 different forms of CT scan morphology in term of : • Mechanical ventilation duration • Mortality at 28 days • Mortality at 90 days

  within 48 hours of enrolment

Study Arms (1)

blood sample

Procedure: blood sample

Interventions

blood sample PROCEDURE

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.

blood sample

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

Defined population

You may qualify if:

• Patients \> 18 years
• Patients within the first 24 hours after onset of ARDS according to the 1994 American-European Consensus Conference (AECC)
• Patients under mechanical ventilation

You may not qualify if:

• Pregnancy
• Acute exacerbation of diabetes
• Dialysis for end-stage kidney disease
• Alzheimer's disease
• Amyloidosis
• Evolutive neoplastic lesion
• Chronic hepatic disease: type C hepatitis, non alcoholic cirrhosis and adenocarcinoma.
• Evolutive COPD
• Patients enrolled in another study

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Michel CONSTANTIN

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)