Acute Respiratory Distress SyndromeNCT01161901
Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome (ARDS) Definition
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Defined population
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Acute exacerbation of diabetes
- Dialysis for end-stage kidney disease
- Alzheimer's disease
- Amyloidosis
- Evolutive neoplastic lesion
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- Chronic hepatic disease: type C hepatitis, non alcoholic cirrhosis and adenocarcinoma.
- Evolutive COPD
- Patients enrolled in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome Definition in Intensive Care Unit
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.
Read more
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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- blood sample
- Keywords
- ARDS, Plasmatic biomarkers, Lung Morphology, Mechanical ventilation, CT scan
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| blood sample | Not described Receives: Procedure: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: within 48 hours of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161901
- Sponsor's protocol ID
- CHU-0078
- Status last verified
- Jul 2014
- First submitted
- 13 Jul 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome Definition in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01161901
- Acronym / sponsor ID
- CHU-0078
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Plasmatic biomarkers, Lung Morphology, Mechanical ventilation, CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sample | – | Procedure: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Defined population
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Pregnancy
- Acute exacerbation of diabetes
- Dialysis for end-stage kidney disease
- Alzheimer's disease
- Amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleThis 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. | Procedure or surgery | blood sample |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel CONSTANTIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.