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Sampling in ARDS Patients Under Inhaled Sedation (ANAISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964155
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Acute Distress Respiratory Biological: Sample Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: The investigators and personals in charge of measuring protein markers in this study will be unaware of the fluid type (either AnaConDa-S® fluid,or undiluted pulmonary edema fluid or plasma). In addition, the study statistician will also be blinded during statistical analyses.
Primary Purpose: Diagnostic
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)
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
Experimental: Patients with SDRA
Patients within 24 hours from meeting the Berlin criteria for moderate or severe ARDS and receiving inhaled sedation with sevoflurane
Biological: Sample
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 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

  2. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients <18 years
  • Lack of deferred informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964155


Contacts
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Contact: Lise Laclautre 33 4 73 754963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU
Clermont-Ferrand, France
Contact: Matthieu Jabaudon         
CHU
Reims, France, 51000
Contact: Joël Cousson       jcousson@chu-reims.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Matthieu Jabaudon CHU de Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03964155    
Other Study ID Numbers: RBHP 2018 JABAUDON 2 - ANAISS
2018-A02596-49 ( Other Identifier: ANSM )
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Acute Respiratory Distress Syndrome
Inhaled Sedation with Sevoflurane
Biological collection