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
1 other identifier
observational
422
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2015
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
July 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedOctober 11, 2018
October 1, 2018
1.8 years
June 23, 2016
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
variables associated with highest and lowest mortality
variables associated with highest and lowest mortality
at 24 hours
Secondary Outcomes (1)
stratification by risk of death
at 24 hours
Eligibility Criteria
All consecutive patients with moderate and severe ARDS admitted into participating intensive care units, and requiring endotracheal intubation and mechanical ventilation.
You may qualify if:
- Patients meeting the Berlin criteria for moderate and severe ARDS.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital del Bierzo
Ponferrada, León, Spain
Hospital Universitario NS de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
Hospital Universitario de A Coruña
A Coruña, Spain
Hospital General de Ciudad Real
Ciudad Real, Spain
Hospital Virgen de La Luz
Cuenca, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario de La Paz
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario de Arrixaca
Murcia, Spain
Hospital Universitario Morales Meseguer
Murcia, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Clinico de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Virgen de la Concha
Zamora, Spain
Related Publications (2)
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.
PMID: 34259448DERIVEDVillar 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.
PMID: 30624279DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesús Villar, MD, PhD
Hospital Universitario Dr. Negrin
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Multidisciplinary Organ Dysfunction Evaluation Research Network
Study Record Dates
First Submitted
June 23, 2016
First Posted
July 19, 2016
Study Start
August 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
October 11, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share