Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study (STANDARDS-2)

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ClinicalTrials.gov Identifier: NCT02836444

Recruitment Status : Completed

First Posted : July 19, 2016

Last Update Posted : October 11, 2018

Sponsor:

Collaborators:

Asociación Científica Pulmón y Ventilación Mecánica

Spanish Research Center for Respiratory Diseases

Information provided by (Responsible Party):

Jesus Villar, Dr. Negrin University Hospital

Study Description

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.

Condition or disease
Acute Respiratory Distress Syndrome

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	422 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study
Actual Study Start Date :	August 1, 2015
Actual Primary Completion Date :	May 1, 2017
Actual Study Completion Date :	May 1, 2017

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

variables associated with highest and lowest mortality [ Time Frame: at 24 hours ]
variables associated with highest and lowest mortality

Secondary Outcome Measures :

stratification by risk of death [ Time Frame: at 24 hours ]
stratification by risk of death

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Patients meeting the Berlin criteria for moderate and severe ARDS.

Exclusion Criteria:

None

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836444

Locations

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Spain
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 General de Ciudad Real
Ciudad Real, Spain
Hospital Virgen de La Luz
Cuenca, Spain
Hospital Universitario de A Coruña
La Coruña, 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

Sponsors and Collaborators

Dr. Negrin University Hospital

Asociación Científica Pulmón y Ventilación Mecánica

Spanish Research Center for Respiratory Diseases

Investigators

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Principal Investigator:	Jesús Villar, MD, PhD	Hospital Universitario Dr. Negrin

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Villar J, Ambrós A, Mosteiro F, Martínez D, Fernández L, Ferrando C, Carriedo D, Soler JA, Parrilla D, Hernández M, Andaluz-Ojeda D, Añón JM, Vidal A, González-Higueras E, Martín-Rodríguez C, Díaz-Lamas AM, Blanco J, Belda J, Díaz-Domínguez FJ, Rico-Feijoó J, Martín-Delgado C, Romera MA, González-Martín JM, Fernández 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.

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Responsible Party:	Jesus Villar, Director, Multidisciplinary Organ Dysfunction Evaluation Research Network, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier:	NCT02836444
Other Study ID Numbers:	ACPVM-2015
First Posted:	July 19, 2016 Key Record Dates
Last Update Posted:	October 11, 2018
Last Verified:	October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome Disease Pathologic Processes	Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury

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