Acute Distress RespiratoryANAISSNCT03964155
Sampling in ARDS Patients Under Inhaled Sedation
A study testing Sample in people with Acute Distress Respiratory, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
The main objective of this study is to compare the protein composition of simultaneously collected undiluted pulmonary edema fluid and AnaConDa-S ® fluid from patients with ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Distress Respiratory
- What is being tested?
- Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 2019to 1 Feb 2021
- 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
- All adult patients within 24 hours from meeting the Berlin criteria for moderate or severe ARDS and receiving inhaled sedation with sevoflurane will be eligible for inclusion into the study.
Who cannot join
- Patients <18 years
- Lack of deferred informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Assessment of a Novel Method for Non-invasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome Patients Receiving Inhaled Sedation With Sevoflurane)
The main objective of this study is to compare the protein composition of simultaneously collected undiluted pulmonary edema fluid and AnaConDa-S ® fluid from patients with ARDS.
In a previous pilot randomized controlled trial, in patients with moderate-severe acute respiratory distress syndrome (ARDS), the use of inhaled sevoflurane improved oxygenation and decreased levels of a marker of lung epithelial injury (soluble receptor for advanced glycation end-products, sRAGE) and of some inflammatory markers (interleukin (IL)-1β, IL-6, IL-8 and tumor necrosis factor (TNF)-α), compared to intravenous midazolam. These results reinforce those from previously published preclinical studies as they suggest a protective effect of sevoflurane from alveolar/systemic inflammation and from reduced epithelial injury and/or improved alveolar fluid clearance, as assessed by plasma soluble receptor for advanced glycation end-products (sRAGE). The results from available studies support the safe use of sevoflurane inhalation through dedicated device is well tolerated, with no major adverse effect, e.g. on renal function or respiratory mechanics, in critically ill patients admitted to the intensive care unit (ICU), including those with ARDS.
Because the investigators group frequently uses sevoflurane in patients with ARDS and are interested in developing further research on the effects of inhaled sedation in ARDS, the current study has been designed to verify whether the same concept could be applied to the filter the investigators use to vaporize sevoflurane in their ICUs.
Read the detailed description
Patients with moderate-to-severe ARDS (within 24 hours of onset) and already receiving inhaled sevoflurane for sedation as a current practice in participating centers will be enrolled in this observational study.
After an exposure duration of at least 12 hours, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected concurrently with AnaConDa-S®filter collection. This sample will be the only specific intervention of this study.
Patient data prospectively collected from the medical record will include demographics, ARDS risk factor, chest x-ray, ventilator settings at the time of AnaConDa-S ® filter collection, hospital and ICU length of stay and hospital mortality. Murray's lung injury score and the Acute Physiology and Chronic Health Evaluation (APACHE) II score will be calculated from data already available in the medical record.
AnaConDa-S ® filters will transported to the laboratory on ice and centrifuged at 2,000 x g for 10 minutes to collect condensed fluid that will be subsequently aliquoted and stored at -80°C for further analysis. Undiluted pulmonary edema fluid will be centrifuged at 2,000 x g for 10 minutes. Supernatants will be aliquoted and stored at - 80°C. Levels of IL-1β, IL-6, IL-8, TNF-α, soluble TNF-receptor 1, angiopoietin-2, and sRAGE will be measured in duplicate in both types of fluid with Multiplex.
- Conditions
- Acute Distress Respiratory
- Being tested
- Sample
- Keywords
- Acute Respiratory Distress Syndrome, Inhaled Sedation with Sevoflurane, Biological collection
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SampleBiological
After an exposure duration of at least 12 hours, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected concurrently with AnaConDa-S® filter collection.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SDRA | Experimental | Patients within 24 hours from meeting the Berlin criteria for moderate or severe ARDS and receiving inhaled sedation with sevoflurane Receives: Biological: Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparaison between levels of protein markers, measured IL-1β, IL-6, IL-8, TNF-α, soluble TNF-receptor 1, angiopoietin-2, and sRAGE, measured in undiluted pulmonary edema fluid and in AnaConDa-S ® fluid
After an exposure duration of at least 12 hours, and when clinically available, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected (in general, only few ml are collected) concurrently with AnaConDa-S® filter collection. The concordance between levels of markers measured from undiluted alveolar fluid and those measured from AnaConDa-S® fluid will be explored using Lin's concordance coefficient, correlation coefficient (Pearson or Spearman according to the statistical distribution) and Bland-Altman plot. Confidence intervals at 95% will be presented. To complete these analyses, the satisfactory agreement will be confirmed by Passing and Bablok regression in order to highlight non-systematic and non-proportional differences between the two methods (undiluted pulmonary edema fluid and AnaConDa-S® fluid).
Measured: Between 12 hours and 24 hours after the begining of Sevoflurane sedation
Secondary outcomes (2)
Comparisons of levels of protein markers measured in AnaConDa-S® fluid between patients with focal ARDS and those with nonfocal ARDS
The levels of protein markers measured in AnaConDa-S® fluid will be compared between patients with focal ARDS and those with nonfocal ARDS using the unpaired t test or the Mann-Whitney U test when appropriate
Measured: Between 12 hours and 24 hours after the begining of Sevoflurane sedation
The correlation between levels of protein markers measured in AnaConDa-S® and the Radiographic Assessment of Lung Edema (RALE) score developed recently by Pr. Lorraine Ware's team at Vanderbilt University.
The relationships between the levels of protein markers measured in AnaConDa-S® and the Radiographic Assessment of Lung Edema (RALE) score will be studied using correlation coefficients.
Measured: Between 12 hours and 24 hours after the begining of Sevoflurane sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Why it stopped: Logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Distress RespiratoryStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Analysize correlation between sample from undiluted pulmonary edema andsample from AnaConDa-S® filter from patients presenting ARDS since 24 hours and sedated with inhaled sevoflurane.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Jabaudon, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964155
- Sponsor's protocol ID
- RBHP 2018 JABAUDON 2 - ANAISS
- Other IDs
- 2018-A02596-49
- Acronym
- ANAISS
- Status last verified
- Aug 2021
- First submitted
- 21 May 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Novel Method for Non-invasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome Patients Receiving Inhaled Sedation With Sevoflurane)
- ClinicalTrials.gov ID
- NCT03964155
- Acronym / sponsor ID
- ANAISS / RBHP 2018 JABAUDON 2 - ANAISS
- Conditions
- Acute Distress Respiratory
- Keywords
- Acute Respiratory Distress Syndrome, Inhaled Sedation with Sevoflurane, Biological collection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 28 May 2019 (actual)
- 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 main objective of this study is to compare the protein composition of simultaneously collected undiluted pulmonary edema fluid and AnaConDa-S ® fluid from patients with ARDS.
In a previous pilot randomized controlled trial, in patients with moderate-severe acute respiratory distress syndrome (ARDS), the use of inhaled sevoflurane improved oxygenation and decreased levels of a marker of lung epithelial injury (soluble receptor for advanced glycation end-products, sRAGE) and of some inflammatory markers (interleukin (IL)-1β, IL-6, IL-8 and tumor necrosis factor (TNF)-α), compared to intravenous midazolam. These results reinforce those from previously published preclinical studies as they suggest a protective effect of sevoflurane from alveolar/systemic inflammation and from reduced epithelial injury and/or improved alveolar fluid clearance, as assessed by plasma soluble receptor for advanced glycation end-products (sRAGE). The results from available studies support the safe use of sevoflurane inhalation through dedicated device is well tolerated, with no major adverse effect, e.g. on renal function or respiratory mechanics, in critically ill patients admitted to the intensive care unit (ICU), including those with ARDS.
Because the investigators group frequently uses sevoflurane in patients with ARDS and are interested in developing further research on the effects of inhaled sedation in ARDS, the current study has been designed to verify whether the same concept could be applied to the filter the investigators use to vaporize sevoflurane in their ICUs.
Detailed description
Patients with moderate-to-severe ARDS (within 24 hours of onset) and already receiving inhaled sevoflurane for sedation as a current practice in participating centers will be enrolled in this observational study.
After an exposure duration of at least 12 hours, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected concurrently with AnaConDa-S®filter collection. This sample will be the only specific intervention of this study.
Patient data prospectively collected from the medical record will include demographics, ARDS risk factor, chest x-ray, ventilator settings at the time of AnaConDa-S ® filter collection, hospital and ICU length of stay and hospital mortality. Murray's lung injury score and the Acute Physiology and Chronic Health Evaluation (APACHE) II score will be calculated from data already available in the medical record.
AnaConDa-S ® filters will transported to the laboratory on ice and centrifuged at 2,000 x g for 10 minutes to collect condensed fluid that will be subsequently aliquoted and stored at -80°C for further analysis. Undiluted pulmonary edema fluid will be centrifuged at 2,000 x g for 10 minutes. Supernatants will be aliquoted and stored at - 80°C. Levels of IL-1β, IL-6, IL-8, TNF-α, soluble TNF-receptor 1, angiopoietin-2, and sRAGE will be measured in duplicate in both types of fluid with Multiplex.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Analysize correlation between sample from undiluted pulmonary edema andsample from AnaConDa-S® filter from patients presenting ARDS since 24 hours and sedated with inhaled sevoflurane.
| Arm | Type | Receives |
|---|---|---|
| Patients with SDRA | Experimental | Biological: SamplePatients within 24 hours from meeting the Berlin criteria for moderate or severe ARDS and receiving inhaled sedation with sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients within 24 hours from meeting the Berlin criteria for moderate or severe ARDS and receiving inhaled sedation with sevoflurane will be eligible for inclusion into the study.
Key exclusion criteria (2 listed)
- Patients <18 years
- Lack of deferred informed consent
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 |
|---|---|---|
| SampleAfter an exposure duration of at least 12 hours, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected concurrently with AnaConDa-S® filter collection. | Biological | Patients with SDRA |
Primary outcome
Comparaison between levels of protein markers, measured IL-1β, IL-6, IL-8, TNF-α, soluble TNF-receptor 1, angiopoietin-2, and sRAGE, measured in undiluted pulmonary edema fluid and in AnaConDa-S ® fluid
Time frame: Between 12 hours and 24 hours after the begining of Sevoflurane sedation
After an exposure duration of at least 12 hours, and when clinically available, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected (in general, only few ml are collected) concurrently with AnaConDa-S® filter collection. The concordance between levels of markers measured from undiluted alveolar fluid and those measured from AnaConDa-S® fluid will be explored using Lin's concordance coefficient, correlation coefficient (Pearson or Spearman according to the statistical distribution) and Bland-Altman plot. Confidence intervals at 95% will be presented. To complete these analyses, the satisfactory agreement will be confirmed by Passing and Bablok regression in order to highlight non-systematic and non-proportional differences between the two methods (undiluted pulmonary edema fluid and AnaConDa-S® fluid).
2 secondary outcomes
Comparisons of levels of protein markers measured in AnaConDa-S® fluid between patients with focal ARDS and those with nonfocal ARDS
Time frame: Between 12 hours and 24 hours after the begining of Sevoflurane sedation
The correlation between levels of protein markers measured in AnaConDa-S® and the Radiographic Assessment of Lung Edema (RALE) score developed recently by Pr. Lorraine Ware's team at Vanderbilt University.
Time frame: Between 12 hours and 24 hours after the begining of Sevoflurane sedation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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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.
Matthieu Jabaudon principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sample in people with Acute Distress Respiratory, run by University Hospital, Clermont-Ferrand at 2 sites 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Comparaison between levels of protein markers, measured IL-1β, IL-6, IL-8, TNF-α, soluble TNF-receptor 1, angiopoietin-2, and sRAGE, measured in undiluted pulmonary edema fluid and in AnaConDa-S ® fluid (time frame: Between 12 hours and 24 hours after the begining of Sevoflurane sedation). 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 30 Aug 2021.