Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study (STANDARDS-2)
STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
In 2012, an update of the ARDS definition (The Berlin criteria) was published and an empirical classification was proposed according to three PaO2/FiO2 cut-off values at ARDS onset: severe (≤100 mmHg), moderate (>100 - ≤200 mmHg), and mild (>200 - ≤300 mmHg) on positive end-expiratory pressure (PEEP) ≥5 cmH2O. However, despite that there is sufficient evidence about the interactions between PEEP and FiO2, these cut-off values did not mandate the assessment of hypoxemia under standardized guidelines.
The PaO2/FiO2 can be easily manipulated. Alterations in PEEP and FiO2 can dramatically change the PaO2/FiO2. Despite recent reports on the effects of standardized ventilator settings on PaO2/FiO2, is still a matter of debate whether the assessment of hypoxemia must be performed at 24 hours instead of at ARDS onset, and whether the assessment of hypoxemia under standardized ventilator settings is the most appropriate tool for stratifying lung severity in patients with ARDS.
The investigators will examine whether the values of relevant variables (including age, plateau pressure, driving pressure, compliance, PaO2/FiO2) at 24 after ARDS diagnosis under standardized ventilator settings have an impact on the stratification and prediction of death in ARDS patients. This study is an extension of the study NCT02288949.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Ciudad Real, Spania
- Hospital General de Ciudad Real
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Cuenca, Spania
- Hospital Virgen de La Luz
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La Coruña, Spania
- Hospital Universitario de A Coruña
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Madrid, Spania
- Hospital Universitario 12 de Octubre
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Madrid, Spania
- Hospital Universitario Fundación Jiménez Díaz
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Madrid, Spania
- Hospital Universitario de La Paz
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Murcia, Spania
- Hospital Universitario Morales Meseguer
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Murcia, Spania
- Hospital Universitario de Arrixaca
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Segovia, Spania
- Hospital General de Segovia
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Valencia, Spania
- Hospital Clínico de Valencia
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Valladolid, Spania
- Hospital Clínico Universitario de Valladolid
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Valladolid, Spania
- Hospital Universitario Río Hortega
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Zamora, Spania
- Hospital Virgen de la Concha
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Barcelona
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Terrassa, Barcelona, Spania
- Hospital Universitario Mutua de Terrassa
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León
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Ponferrada, León, Spania
- Hospital del Bierzo
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Tenerife
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Santa Cruz de Tenerife, Tenerife, Spania
- Hospital Universitario NS de Candelaria
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients meeting the Berlin criteria for moderate and severe ARDS.
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
variables associated with highest and lowest mortality
Tidsramme: at 24 hours
|
variables associated with highest and lowest mortality
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at 24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
stratification by risk of death
Tidsramme: at 24 hours
|
stratification by risk of death
|
at 24 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jesús Villar, MD, PhD, Hospital Universitario Dr. Negrin
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Villar J, Gonzalez-Martin JM, Ambros A, Mosteiro F, Martinez D, Fernandez L, Soler JA, Parra L, Solano R, Soro M, Del Campo R, Gonzalez-Luengo RI, Civantos B, Montiel R, Pita-Garcia L, Vidal A, Anon JM, Ferrando C, Diaz-Dominguez FJ, Mora-Ordonez JM, Fernandez MM, Fernandez C, Fernandez RL, Rodriguez-Suarez P, Steyerberg EW, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score. Crit Care Med. 2021 Oct 1;49(10):e920-e930. doi: 10.1097/CCM.0000000000005142.
- Villar J, Ambros A, Mosteiro F, Martinez D, Fernandez L, Ferrando C, Carriedo D, Soler JA, Parrilla D, Hernandez M, Andaluz-Ojeda D, Anon JM, Vidal A, Gonzalez-Higueras E, Martin-Rodriguez C, Diaz-Lamas AM, Blanco J, Belda J, Diaz-Dominguez FJ, Rico-Feijoo J, Martin-Delgado C, Romera MA, Gonzalez-Martin JM, Fernandez RL, Kacmarek RM; Spanish Initiative for Epidemiology, Stratification and Therapies of ARDS (SIESTA) Network. A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials. Crit Care Med. 2019 Mar;47(3):377-385. doi: 10.1097/CCM.0000000000003624.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACPVM-2015
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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