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Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain) (AMIS)

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ClinicalTrials.gov Identifier: NCT02003326
Recruitment Status : Terminated (low number of patients enrolled)
First Posted : December 6, 2013
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Inflammatory markers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
Actual Study Start Date : November 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017


Arm Intervention/treatment
Inflammatory markers
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.
Other: Inflammatory markers



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality at D28 [ Time Frame: at the 28th day ]
    Verify if the patient is death at the 28th day

  2. Ventilatory free days at D28 [ Time Frame: at the 28th day ]
    To determine if the patient is free ventilatory at the 28th day



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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:

  • 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
  • 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

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): NCT02003326


Locations
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France
Réanimation Médicale CHU de Nice - Hôpital de l'Archet
Nice, France, 06003
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Jean DELLAMONICA, MD CHU de Nice Hôpital de l'Archet
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02003326    
Other Study ID Numbers: 13AOI07
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Inflammation
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury