- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02003326
Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain) (AMIS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Nice, Frankrig, 06003
- Réanimation Médicale CHU de Nice - Hôpital de l'Archet
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg
Tidsramme: until the 13th day
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measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13
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until the 13th day
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mortality at D28
Tidsramme: at the 28th day
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Verify if the patient is death at the 28th day
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at the 28th day
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Ventilatory free days at D28
Tidsramme: at the 28th day
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To determine if the patient is free ventilatory at the 28th day
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at the 28th day
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jean DELLAMONICA, MD, CHU de Nice Hopital de L'Archet
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13AOI07
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