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Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
Sponsor: Dr. Negrin University Hospital
Summary
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.
Official title: Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
980
Start Date
2021-07-06
Completion Date
2026-12-30
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone
Intravenous dexamethasone (low vs. moderate doses) during 10 days
Locations (40)
Hospital Universitario Mutua Terrassa (ICU)
Terrassa, Barcelona, Spain
Hospital General La Mancha Centro (ICU)
Alcázar de San Juan, Ciudad Real, Spain
Complejo Hospitalario Universitario de Santiago (Anesthesia)
Santiago de Compostela, La Coruña, Spain
Hospital General El Bierzo (ICU)
Ponferrada, León, Spain
Hospital Universitario del Henares (ICU)
Coslada, Madrid, Spain
Hospital Universitario de Getafe (ICU)
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa (ICU)
Leganés, Madrid, Spain
Hospital Universitario Puerta de Hierro (ICU)
Majadahonda, Madrid, Spain
Hospital Nuestra Señora del Prado (ICU)
Talavera de la Reina, Toledo, Spain
Hospital Universitario de Cruces (Anesthesia)
Barakaldo, Vizcaya, Spain
Hospital Universitario de Cruces (ICU)
Barakaldo, Vizcaya, Spain
Hospital Universitario de A Coruña (ICU)
A Coruña, Spain
Complejo Hospitalario Universitario de Albacete (ICU)
Albacete, Spain
Hospital Clinic de Barcelona (AVI)
Barcelona, Spain
Hospital Clinic de Barcelona (Cardiac ICU)
Barcelona, Spain
Hospital Clínic (Hepatic ICU)
Barcelona, Spain
Hospital Clínic de Barcelona (Anesthesia)
Barcelona, Spain
Hospital General de Ciudad Real (ICU)
Ciudad Real, Spain
Hospital Virgen de la Luz (ICU)
Cuenca, Spain
Complejo Asistencial Universitario de León (ICU)
León, Spain
Hospital Universitario La Princesa (ICU)
Madrid, Spain
Hospital Universitario Ramón y Cajal (Anesthesia)
Madrid, Spain
Hospital Clínico Universitario San Carlos (ICU)
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz (ICU)
Madrid, Spain
Hospital Universitario Doce de Octubre (ICU)
Madrid, Spain
Hospital Universitario La Paz (Anesthesia)
Madrid, Spain
Hospital Universitario La Paz (ICU)
Madrid, Spain
Hospital Universitario Regional de Malaga Carlos Haya (ICU)
Málaga, Spain
Hospital Universitario Virgen de Arrixaca (Anesthesia)
Murcia, Spain
Hospital Universitario Virgen de Arrixaca (ICU)
Murcia, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Universitario Montecelo (Anesthesia)
Pontevedra, Spain
Hospital Universitario Nuestra Señora de Candelaria (ICU)
Santa Cruz de Tenerife, Spain
Hospital General de Segovia (ICU)
Segovia, Spain
Hospital Clinico Universitario de Valencia (Anesthesia)
Valencia, Spain
Hospital Clinico Universitario de Valencia (ICU)
Valencia, Spain
Hospital Clínico Universitario de Valladolid (Anesthesia)
Valladolid, Spain
Hospital Universitario Río Hortega (Anesthesia)
Valladolid, Spain
Hospital Universitario Río Hortega (ICU)
Valladolid, Spain
Hospital Virgen de la Concha (ICU)
Zamora, Spain