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

Sponsor
Dr. Negrin University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02836444
Collaborator
Asociación Científica Pulmón y Ventilación Mecánica (Other), Spanish Research Center for Respiratory Diseases (Other)
422
Enrollment
16
Locations
21
Actual Duration (Months)
26.4
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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

    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 :
    Aug 1, 2015
    Actual Primary Completion Date :
    May 1, 2017
    Actual Study Completion Date :
    May 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. variables associated with highest and lowest mortality [at 24 hours]

      variables associated with highest and lowest mortality

    Secondary Outcome Measures

    1. stratification by risk of death [at 24 hours]

      stratification by risk of death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients meeting the Berlin criteria for moderate and severe ARDS.
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Mutua de Terrassa Terrassa Barcelona Spain
    2 Hospital del Bierzo Ponferrada León Spain
    3 Hospital Universitario NS de Candelaria Santa Cruz de Tenerife Tenerife Spain
    4 Hospital General de Ciudad Real Ciudad Real Spain
    5 Hospital Virgen de La Luz Cuenca Spain
    6 Hospital Universitario de A Coruña La Coruña Spain
    7 Hospital Universitario 12 de Octubre Madrid Spain
    8 Hospital Universitario de La Paz Madrid Spain
    9 Hospital Universitario Fundación Jiménez Díaz Madrid Spain
    10 Hospital Universitario de Arrixaca Murcia Spain
    11 Hospital Universitario Morales Meseguer Murcia Spain
    12 Hospital General de Segovia Segovia Spain
    13 Hospital Clinico de Valencia Valencia Spain
    14 Hospital Clínico Universitario de Valladolid Valladolid Spain
    15 Hospital Universitario Río Hortega Valladolid Spain
    16 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

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 19, 2016
    Last Update Posted:
    Oct 11, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury
    Syndrome

    Study Results

    No Results Posted as of Oct 11, 2018