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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 422

Contacts and Locations

Study Locations

• Spain
  • Ciudad Real, Spain
    • Hospital General de Ciudad Real
  • Cuenca, Spain
    • Hospital Virgen De La Luz
  • La Coruña, Spain
    • Hospital Universitario de A Coruna
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital Universitario de La Paz
  • Murcia, Spain
    • Hospital Universitario Morales Meseguer
  • Murcia, Spain
    • Hospital Universitario de Arrixaca
  • Segovia, Spain
    • Hospital General de Segovia
  • Valencia, Spain
    • Hospital Clinico de Valencia
  • Valladolid, Spain
    • Hospital Clínico Universitario de Valladolid
  • Valladolid, Spain
    • Hospital Universitario Río Hortega
  • Zamora, Spain
    • Hospital Virgen de la Concha
  • Barcelona
    • Terrassa, Barcelona, Spain
      • Hospital Universitario Mutua de Terrassa
  • León
    • Ponferrada, León, Spain
      • Hospital del Bierzo
  • Tenerife
    • Santa Cruz de Tenerife, Tenerife, Spain
      • Hospital Universitario NS de Candelaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variables associated with highest and lowest mortality	variables associated with highest and lowest mortality	at 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stratification by risk of death	stratification by risk of death	at 24 hours

Collaborators and Investigators

• Sponsor: Dr. Negrin University Hospital
• Collaborators: Spanish Research Center for Respiratory Diseases; Asociación Científica Pulmón y Ventilación Mecánica
• Investigators: Principal Investigator: Jesús Villar, MD, PhD, Hospital Universitario Dr. Negrin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ACPVM-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO