Acute Respiratory InsufficiencyBIO-IRANCT00835809
Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic
An observational study of Acute Respiratory Insufficiency, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear. We propose to determine the more relevant marker combination in this case. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Insufficiency
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Oct 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency and unit intensive care patient.
Who may be able to join
- Oxygen saturation below or equal to 92% in ambient air.
- Respiratory frequence above 25 cycle per minute
Who cannot join
- Minors
- Pregnant or lactating women
- Patient without social security
- Patient hospitalize without consent
- Chest pain with acute coronary electro-cardiographic change leading immediate achievement of a diagnostic coronary angiography and/or therapeutic
- Pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.
We propose to determine the more relevant marker combination in this case.
Read the detailed description
In urgence of a severe acute respiratory insufficiency,for thanks to an approach diagnostic, therapeutic and prognostic we propose to determine the more relevant biomarker combination.
An expert committee will compare the biomarker diagnostic and prognostic relevance thanks to all elements clinico-biological and patient monitoring.
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- Acute respiratory insufficiency respiratory, Biomarkers, Emergency, Intensive care unit, Prospective, Patient hospitalize in emergency or in intensive care unit, for acute respiratory insufficiency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute respiratory diseases. | Patient admit in emergency or intensive care unite with acute respiratory insufficiency. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Clinical Research
- Investigators
- ARA SOMOHANO Claire, PH, Principal investigator, Emergency NGO Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835809
- Sponsor's protocol ID
- 0811
- Other IDs
- 2008-A00703-52
- Acronym
- BIO-IRA
- Status last verified
- Sep 2010
- First submitted
- 3 Feb 2009
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Marker Approach Interest in Emergency in Acute Respiratory Insufficiency Diagnostic
- ClinicalTrials.gov ID
- NCT00835809
- Acronym / sponsor ID
- BIO-IRA / 0811
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- Acute respiratory insufficiency respiratory, Biomarkers, Emergency, Intensive care unit, Prospective, Patient hospitalize in emergency or in intensive care unit, for acute respiratory insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Regional Clinical Research
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Feb 2009 (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.
Biomarkers have an interest in clinic diagnostic ,therapeutic and prognosis in pathophysiologic situation including cardiovascular.But interest of biomarkers in diagnostic care of severe acute respiratory insufficiency remains to clear.
We propose to determine the more relevant marker combination in this case.
Detailed description
In urgence of a severe acute respiratory insufficiency,for thanks to an approach diagnostic, therapeutic and prognostic we propose to determine the more relevant biomarker combination.
An expert committee will compare the biomarker diagnostic and prognostic relevance thanks to all elements clinico-biological and patient monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute respiratory diseases. | – | –Patient admit in emergency or intensive care unite with acute respiratory insufficiency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency and unit intensive care patient.
Key inclusion criteria (2 listed)
- Oxygen saturation below or equal to 92% in ambient air.
- Respiratory frequence above 25 cycle per minute
Key exclusion criteria (6 listed)
- Minors
- Pregnant or lactating women
- Patient without social security
- Patient hospitalize without consent
- Chest pain with acute coronary electro-cardiographic change leading immediate achievement of a diagnostic coronary angiography and/or therapeutic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Sep 2010.
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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.
ARA SOMOHANO Claire, PH principal investigator
Emergency NGO Onlus
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 Insufficiency, run by University Hospital, Grenoble 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 2 inclusion and 6 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 Sep 2010. 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.
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 Sep 2010.