Acute Respiratory Distress SyndromeAMISNCT02003326
Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
A study testing Inflammatory markers in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS). 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?
- Inflammatory markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- Moderate to severe ARDS (Berlin Definition)
- Acute beginning <1 week
- PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
- Bilateral opacities on chest X-ray
- Respiratory failure not fully explain by cardiac failure or fluid overload
- Informed consent signed by the next of kin and secondarily by the patient when awake
Show all 14Show fewer
- Patient with social insurance
- No Inclusion criteria
- Age < 18
- Pregnancy a pregnancy test will be done to women of childbearing age
- Chronic obstructive pulmonary disease
- Severe hypoxemia PaO2/FiO2 <50% with high PEEP
- Immunosuppressive treatment
- Immunodeficiency onco-hematology, HIV
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Réanimation Médicale CHU de Nice - Hôpital de l'Archet
Nice, 06003
About this study
The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).
Read the detailed description
Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.
The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.
Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Inflammatory markers
- 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.
Inflammatory markersOther
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory markers | Other | All patients with inclusion criteria (ARDS moderate and severe: Berlin definition) and absence of non inclusion criteria will have a broncho alveolar wash at day 0 and blood sample every three day to measure inflammatory markers. All patients will receive protective ventilation with low tidal volume and pressures limited (Pplat <30cmH2O). End-Expiratory Lung Volume and strain will be measured every 6 hours from the inclusion to the extubation. Receives: Other: Inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13
Measured: until the 13th day
Secondary outcomes (2)
Mortality at D28
Verify if the patient is death at the 28th day
Measured: at the 28th day
Ventilatory free days at D28
To determine if the patient is free ventilatory at the 28th day
Measured: at the 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: low number of patients enrolled
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 Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean DELLAMONICA, MD, Principal investigator, CHU de Nice Hôpital de l'Archet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003326
- Sponsor's protocol ID
- 13AOI07
- Acronym
- AMIS
- Status last verified
- Oct 2017
- First submitted
- 7 Nov 2013
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
- ClinicalTrials.gov ID
- NCT02003326
- Acronym / sponsor ID
- AMIS / 13AOI07
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low number of patients enrolled
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 6 Dec 2013 (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 objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).
Detailed description
Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.
The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.
Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory markers | Other | Other: Inflammatory markersAll patients with inclusion criteria (ARDS moderate and severe: Berlin definition) and absence of non inclusion criteria will have a broncho alveolar wash at day 0 and blood sample every three day to measure inflammatory markers. All patients will receive protective ventilation with low tidal volume and pressures limited (Pplat <30cmH2O). End-Expiratory Lung Volume and strain will be measured every 6 hours from the inclusion to the extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Moderate to severe ARDS (Berlin Definition)
- Acute beginning <1 week
- PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
- Bilateral opacities on chest X-ray
- Respiratory failure not fully explain by cardiac failure or fluid overload
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Inflammatory markers | Other | Inflammatory markers |
Primary outcome
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg
Time frame: until the 13th day
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13
2 secondary outcomes
Mortality at D28
Time frame: at the 28th day
Ventilatory free days at D28
Time frame: at the 28th day
Results and safety
The study was stopped early (reason given: low number of patients enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
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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 DELLAMONICA, MD principal investigator
CHU de Nice Hôpital de l'Archet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflammatory markers in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire de Nice 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 14 inclusion and 0 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: stopped early, as of the sponsor's last update on 5 Oct 2017. 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 was stopped early (reason given: low number of patients enrolled). Results are not available in the source record.
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?
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg (time frame: until the 13th day). 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 5 Oct 2017.