Sampling in ARDS Patients Under Inhaled Sedation

NCT03964155 | Withdrawn

• 2 other identifiers: RBHP 2018 JABAUDON 2 - ANAISS2018-A02596-49
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Distress Respiratory

Keywords

Acute Respiratory Distress Syndrome; Inhaled Sedation with Sevoflurane; Biological collection

Outcome Measures

Primary Outcomes (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

  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).

  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

  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.

  Between 12 hours and 24 hours after the begining of Sevoflurane sedation

Study Arms (1)

Patients with SDRA

EXPERIMENTAL

Patients within 24 hours from meeting the Berlin criteria for moderate or severe ARDS and receiving inhaled sedation with sevoflurane

Biological: Sample

Interventions

Sample BIOLOGICAL

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.

Patients with SDRA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients \<18 years
• Lack of deferred informed consent

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU

Clermont-Ferrand, France

Location

CHU

Reims, 51000, France

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Matthieu Jabaudon

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 28, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

FR (2)