Actively Recruiting
Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
Led by Dr. Negrin University Hospital · Updated on 2025-08-26
980
Participants Needed
40
Research Sites
286 weeks
Total Duration
On this page
Sponsors
D
Dr. Negrin University Hospital
Lead Sponsor
L
Li Ka Shing Knowledge Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial. Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.
CONDITIONS
Official Title
Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Intubated and mechanically ventilated
- Acute onset of acute hypoxemic respiratory failure (AHRF) defined by PaO2/FiO2 300 mmHg for at least 6 hours
- Positive end-expiratory pressure (PEEP) of at least 5 cmH2O and FiO2 of at least 0.3 for PaO2/FiO2 measurement
- ARDS defined by Berlin criteria including pneumonia or worsening respiratory symptoms, bilateral pulmonary infiltrates on chest imaging, absence of left heart failure signs, and hypoxemia
- Pulmonary or systemic infection causing AHRF
You will not qualify if you...
- Known contraindication to corticosteroids
- Participation in another therapeutic clinical trial
- Lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Hospital Universitario Mutua Terrassa (ICU)
Terrassa, Barcelona, Spain, 08221
Not Yet Recruiting
2
Hospital General La Mancha Centro (ICU)
Alcázar de San Juan, Ciudad Real, Spain, 13600
Not Yet Recruiting
3
Complejo Hospitalario Universitario de Santiago (Anesthesia)
Santiago de Compostela, La Coruña, Spain, 15706
Not Yet Recruiting
4
Hospital General El Bierzo (ICU)
Ponferrada, León, Spain, 24404
Not Yet Recruiting
5
Hospital Universitario del Henares (ICU)
Coslada, Madrid, Spain, 28822
Not Yet Recruiting
6
Hospital Universitario de Getafe (ICU)
Getafe, Madrid, Spain, 28905
Not Yet Recruiting
7
Hospital Universitario Severo Ochoa (ICU)
Leganés, Madrid, Spain, 28911
Not Yet Recruiting
8
Hospital Universitario Puerta de Hierro (ICU)
Majadahonda, Madrid, Spain, 28222
Not Yet Recruiting
9
Hospital Nuestra Señora del Prado (ICU)
Talavera de la Reina, Toledo, Spain, 45600
Not Yet Recruiting
10
Hospital Universitario de Cruces (Anesthesia)
Barakaldo, Vizcaya, Spain, 48903
Not Yet Recruiting
11
Hospital Universitario de Cruces (ICU)
Barakaldo, Vizcaya, Spain, 48903
Not Yet Recruiting
12
Hospital Universitario de A Coruña (ICU)
A Coruña, Spain, 15006
Not Yet Recruiting
13
Complejo Hospitalario Universitario de Albacete (ICU)
Albacete, Spain, 02006
Not Yet Recruiting
14
Hospital Clinic de Barcelona (AVI)
Barcelona, Spain, 08036
Not Yet Recruiting
15
Hospital Clinic de Barcelona (Cardiac ICU)
Barcelona, Spain, 08036
Not Yet Recruiting
16
Hospital Clínic (Hepatic ICU)
Barcelona, Spain, 08036
Not Yet Recruiting
17
Hospital Clínic de Barcelona (Anesthesia)
Barcelona, Spain, 08036
Actively Recruiting
18
Hospital General de Ciudad Real (ICU)
Ciudad Real, Spain, 13005
Not Yet Recruiting
19
Hospital Virgen de la Luz (ICU)
Cuenca, Spain, 16002
Not Yet Recruiting
20
Complejo Asistencial Universitario de León (ICU)
León, Spain, 24001
Not Yet Recruiting
21
Hospital Universitario La Princesa (ICU)
Madrid, Spain, 28006
Not Yet Recruiting
22
Hospital Universitario Ramón y Cajal (Anesthesia)
Madrid, Spain, 28034
Not Yet Recruiting
23
Hospital Clínico Universitario San Carlos (ICU)
Madrid, Spain, 28040
Not Yet Recruiting
24
Hospital Universitario Fundación Jiménez Díaz (ICU)
Madrid, Spain, 28040
Not Yet Recruiting
25
Hospital Universitario Doce de Octubre (ICU)
Madrid, Spain, 28041
Not Yet Recruiting
26
Hospital Universitario La Paz (Anesthesia)
Madrid, Spain, 28046
Not Yet Recruiting
27
Hospital Universitario La Paz (ICU)
Madrid, Spain, 28046
Actively Recruiting
28
Hospital Universitario Regional de Malaga Carlos Haya (ICU)
Málaga, Spain, 29010
Not Yet Recruiting
29
Hospital Universitario Virgen de Arrixaca (Anesthesia)
Murcia, Spain, 30120
Not Yet Recruiting
30
Hospital Universitario Virgen de Arrixaca (ICU)
Murcia, Spain, 30120
Not Yet Recruiting
31
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Not Yet Recruiting
32
Hospital Universitario Montecelo (Anesthesia)
Pontevedra, Spain, 36071
Not Yet Recruiting
33
Hospital Universitario Nuestra Señora de Candelaria (ICU)
Santa Cruz de Tenerife, Spain, 38010
Not Yet Recruiting
34
Hospital General de Segovia (ICU)
Segovia, Spain, 40002
Not Yet Recruiting
35
Hospital Clinico Universitario de Valencia (Anesthesia)
Valencia, Spain, 46010
Not Yet Recruiting
36
Hospital Clinico Universitario de Valencia (ICU)
Valencia, Spain, 46010
Actively Recruiting
37
Hospital Clínico Universitario de Valladolid (Anesthesia)
Valladolid, Spain, 47003
Not Yet Recruiting
38
Hospital Universitario Río Hortega (Anesthesia)
Valladolid, Spain, 47012
Not Yet Recruiting
39
Hospital Universitario Río Hortega (ICU)
Valladolid, Spain, 47012
Actively Recruiting
40
Hospital Virgen de la Concha (ICU)
Zamora, Spain, 49022
Not Yet Recruiting
Research Team
J
Jesús Villar, MD
CONTACT
A
Arthur Slutsky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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