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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01161901
First received: July 13, 2010
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome
Procedure: blood sample

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome Definition in Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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. [ Time Frame: within 24 hours of enrolment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare the 2 different forms of CT scan morphology in term of : • Mechanical ventilation duration • Mortality at 28 days • Mortality at 90 days [ Time Frame: within 48 hours of enrolment ] [ Designated as safety issue: Yes ]

Enrollment: 134
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
blood sample Procedure: blood sample

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.


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Defined population

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01161901

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01161901     History of Changes
Other Study ID Numbers: CHU-0078
Study First Received: July 13, 2010
Last Updated: July 4, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
ARDS
Plasmatic biomarkers
Lung Morphology
Mechanical ventilation
CT scan

Additional relevant MeSH terms:
Inflammation
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 28, 2014