Stratification of the Acute Respiratory Distress Syndrome

NCT02288949 | Completed

• 1 other identifier: ACPVM-2014
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The American-European Consensus Conference (AECC) and the Berlin definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for epidemiologic studies, but it is not adequate for inclusion of patients into therapeutic clinical trials. Despite recent reports on the effects of standardized ventilator settings on PaO2/FIO2 and fulfillment of AECC and Berlin definitions of ARDS, it is still a matter of debate whether the assessment of hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients with ARDS. The investigators will perform an observational, multicenter, prospective audit in a network of intensive care units in Spain and China for validating and confirming that the assessment of hypoxemia at 24 hours after ARDS onset is the most valuable tool for stratifying and predicting outcome in patients with ARDS.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

mechanical ventilation, stratificacion, lung severity

Outcome Measures

Primary Outcomes (1)

• range of values of variables associated with the highest or lowest mortality

  within the first 24 h of ARDS onset

Secondary Outcomes (1)

• stratification by risk of death based on variables associated with worst outcome

  ICU stay

Study Arms (1)

Prospective cohort

Stratification of patients admitted into a network of Spanish ICUs.

Other: stratification

Interventions

stratification OTHER

Patients will be stratified based on the values of relevant demographics, pulmonary and systemic variables in relation to mortality in the intensive care unit.

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive ARDS patients

You may qualify if:

• Patients meeting the AECC definition for ARDS on PEEP greater or equal than 5 cmH2O (or the Berlin criteria for moderate and severe ARDS).

You may not qualify if:

• None

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead
• Asociación Científica Pulmón y Ventilación Mecánica: collaborator

Study Sites (1)

Hospital Virgen de la Luz

Cuenca, 16002, Spain

Location

Related Publications (3)

• 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: 34259448 DERIVED

• 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.

  PMID: 30624279 DERIVED

• Villar J, Martinez D, Mosteiro F, Ambros A, Anon JM, Ferrando C, Soler JA, Montiel R, Vidal A, Conesa-Cayuela LA, Blanco J, Arrojo R, Solano R, Capilla L, Del Campo R, Civantos B, Fernandez MM, Aldecoa C, Parra L, Gutierrez A, Martinez-Jimenez C, Gonzalez-Martin JM, Fernandez RL, Kacmarek RM; Stratification and Outcome of Acute Respiratory Distress Syndrome (STANDARDS) Network. Is Overall Mortality the Right Composite Endpoint in Clinical Trials of Acute Respiratory Distress Syndrome? Crit Care Med. 2018 Jun;46(6):892-899. doi: 10.1097/CCM.0000000000003022.

  PMID: 29420341 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Vernalization

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Plant Development; Growth and Development; Physiological Phenomena; Plant Physiological Phenomena

Study Officials

• Jesús Villar, MD, PhD

  Hospital Universitario Dr. Negrin

  PRINCIPAL INVESTIGATOR

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: November 5, 2014
• First Posted: November 13, 2014
• Study Start: September 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

ES (1)