Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial.
Jesús Villar, Carlos Ferrando, Domingo Martínez...
https://pubmed.ncbi.nlm.nih.gov/32043986Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID04545242
Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure Including ARDS Caused by Infections Including COVID-19
Led by Dr. Negrin University Hospital · Updated on 2025-08-26
980
Participants Needed
40
Research Sites
N/A
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
Researchers are examining the use of dexamethasone in adults with acute hypoxemic respiratory failure (AHRF), including acute respiratory distress syndrome (ARDS), caused by infections such as COVID-19. This condition leads to severe lung inflammation requiring mechanical ventilation and has high mortality rates. The effectiveness of corticosteroids like dexamethasone in treating AHRF and ARDS remains uncertain, prompting this study to compare different dosing strategies to better understand their impact on patient outcomes. The trial is a randomized, controlled, open-label study conducted across multiple centers in Spain. Participants who are mechanically ventilated with confirmed infection-related AHRF will be assigned to receive either a low dose of dexamethasone (6 mg daily for 10 days) or a higher dose (20 mg daily for 5 days, followed by 10 mg daily for 5 days). The study compares these two dosing regimens to determine which may better reduce mortality and improve ventilator-free days. During the trial, participants will be closely monitored in intensive care units, with primary outcomes measured by mortality at 60 days and secondary outcomes by the number of days free from mechanical ventilation within 28 days. Researchers will gather data on lung function, infection status, and overall health. Participants' progress will be followed to assess the safety and effects of the dexamethasone doses over the study period.
CONDITIONS
Brief Title
Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
Who Can Participate
Age: 18Years +
All Genders
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
- AHRF caused by pulmonary or systemic infections
- ARDS defined by Berlin criteria including pneumonia or worsening respiratory symptoms, bilateral lung infiltrates on imaging, no signs of left heart failure, and hypoxemia with PEEP ≥5 cmH2O
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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 days
Participants receive intravenous dexamethasone at either low or moderate doses for 10 days to treat acute hypoxemic respiratory failure caused by infections.
Daily visits during treatment
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
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Research Team
J
Jesús Villar, MD
A
Arthur Slutsky, MD
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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Published Research Related To This Trial
Dexamethasone in Hospitalized Patients with Covid-19.
RECOVERY Collaborative Group, Peter Horby, Wei Shen Lim...
https://pubmed.ncbi.nlm.nih.gov/32678530