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

Acute Respiratory Distress Syndrome Clinical Trial

— STANDARDS-2  

Official title:

STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836444
• Other study ID #: ACPVM-2015
• Status: Completed
• Start date: August 1, 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: October 2018
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
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 del Bierzo	Ponferrada	León
Spain	Hospital Universitario NS de Candelaria	Santa Cruz de Tenerife	Tenerife
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona
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

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital	Asociación Científica Pulmón y Ventilación Mecánica, Spanish Research Center for Respiratory Diseases

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variables associated with highest and lowest mortality	variables associated with highest and lowest mortality	at 24 hours
Secondary	stratification by risk of death	stratification by risk of death	at 24 hours