Clinical trial NCT02836444: Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study
Official title: STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: Asociación Científica Pulmón y Ventilación Mecánica
name: Spanish Research Center for Respiratory Diseases
First posted: 2016-07-19
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients with moderate and severe ARDS admitted into participating intensive care units, and requiring endotracheal intubation and mechanical ventilation.

Brief summary: Current definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for epidemiological studies but are not adequate for inclusion of patients into therapeutic clinical trials. It is a matter of debate whether the assessment of hypoxemia at ARDS onset is appropriate for stratifying lung severity and risk of death in ARDS patients. The investigators will perform an observational, non-interventional, multicenter, prospective audit in a network of intensive care units in Spain for evaluating the severity and risk of death based on the assessment of respiratory and ventilatory function at 24 hours after ARDS diagnosis under standardized ventilatory conditions. This study is the confirmatory phase of the study NCT02288949.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients meeting the Berlin criteria for moderate and severe ARDS.

Exclusion Criteria:

* None

Primary outcomes:
measure: variables associated with highest and lowest mortality
timeFrame: at 24 hours
Secondary outcomes:
measure: stratification by risk of death
timeFrame: at 24 hours
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Ponferrada
country: Spain
facility: Hospital del Bierzo
state: León
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario NS de Candelaria
state: Tenerife
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Cuenca
country: Spain
facility: Hospital Virgen de La Luz
city: La Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Murcia
country: Spain
facility: Hospital Universitario de Arrixaca
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
Study officials:
affiliation: Hospital Universitario Dr. Negrin
name: Jesús Villar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.