A comparative, randomised controlled trial for evaluating the efficacy of dexamethasone administration in the treatment of patients with the Acute Respiratory Distress Syndrome

• Conditions: Acute respiratory distress syndrome (ARDS); MedDRA version: 14.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-000775-17-ES
• Lead Sponsor: Jesús Villar Hernández

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-19
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To be eligible for inclusion into this study (Day 0), each patient must fulfil the following inclusion criteria during screening and prior to the enrolment into the study:

a.Age >=18 years old
b.Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS:
i.Having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.).
ii.bilateral infiltrates on frontal chest radiograph
iii.absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure
iv.severe hypoxemia (a PaO2/FIO2 <=200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
c.Be intubated and mechanically ventilated
d.Have provided signed written informed consent from the patient or the patient's personal legal representative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 264
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

To be eligible for inclusion into this study (Day 0), each patient must not have any of the following exclusion criteria during screening and prior to the enrolment into the study:

e.Be a woman known to be pregnant or lactating
f.Take part in another experimental treatment protocol (simultaneously)
g.Brain death
h.Terminal-stage cancer or other terminal disease
i.Having do-not-resuscitate orders
j.Being immune-compromised
k.Receiving corticosteroids or immunosuppressive drugs
l.Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
m.Have severe chronic obstructive pulmonary disease (COPD)
n.Have congestive heart failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of dexamethasone in increasing by the number of ventilator-free days days (VFDs) at 28 days;Secondary Objective: To evaluate the efficacy of dexamethasone in reducing overall mortality.;Primary end point(s): Number of ventilator free-days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated >=28 days and for subjects who die, VFD is 0.;Timepoint(s) of evaluation of this end point: 60 days after discharge

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -All-cause mortality at Day 60 after enrolment.<br>-Mortality at ICU and hospital discharge<br>-Duration (in days) on mechanical ventilation<br>-Number of extra-pulmonary organ failures (we will consider central nervous system, heart, kidney, gastrointestinal, liver, coagulation, and shock).;Timepoint(s) of evaluation of this end point: 60 days after discharge