Acute respiratory distress syndrome (ARDS) MedDRA version: 14.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Dexametasona
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexamethasone
CAS Number: 50-02-2
Other descriptive name: DEXAMETHASONE
Sponsors
Jesús Villar Hernández
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): -All-cause mortality at Day 60 after enrolment. -Mortality at ICU and hospital discharge -Duration (in days) on mechanical ventilation -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 | — |
Countries
Spain
Contacts
Public ContactRosa Lidia Fernández
Unidad de Investigación. Hosp Univ de GC Dr. Negrín
Outcome results
None listed