Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study

NCT ID: NCT02836444

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 422 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2017-05-01

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociación Científica Pulmón y Ventilación Mecánica

OTHER

Sponsor Role: collaborator

Spanish Research Center for Respiratory Diseases

OTHER

Sponsor Role: collaborator

Dr. Negrin University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jesus Villar

Director, Multidisciplinary Organ Dysfunction Evaluation Research Network

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesús Villar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Dr. Negrin

Locations

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

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 34259448 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30624279 (View on PubMed)

Other Identifiers

ACPVM-2015

Identifier Type: -

Identifier Source: org_study_id