Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Layout table for study information
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





Primary Outcome Measures :
  1. variables associated with highest and lowest mortality [ Time Frame: at 24 hours ]
    variables associated with highest and lowest mortality


Secondary Outcome Measures :
  1. stratification by risk of death [ Time Frame: at 24 hours ]
    stratification by risk of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jesús Villar, MD, PhD Hospital Universitario Dr. Negrin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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:
Layout table for MeSH terms
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