Condition: Acute Hypoxemic Respiratory Failure · Sponsor: Hospital Universitario de Gran Canaria Doctor Negrín
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.
This description comes directly from the study's public registry record.
Jesús Villar, MD · +34606860027 · jesus.villar54@gmail.com
Arthur Slutsky, MD · +14168244000 · Arthur.Slutsky@unityhealth.to
Always discuss trial participation with your own doctor first.
| Hospital Universitario Mutua Terrassa (ICU) | Terrassa, Barcelona, Spain | Not Yet Recruiting |
| Hospital General La Mancha Centro (ICU) | Alcázar de San Juan, Ciudad Real, Spain | Not Yet Recruiting |
| Complejo Hospitalario Universitario de Santiago (Anesthesia) | Santiago de Compostela, La Coruña, Spain | Not Yet Recruiting |
| Hospital General El Bierzo (ICU) | Ponferrada, León, Spain | Not Yet Recruiting |
| Hospital Universitario del Henares (ICU) | Coslada, Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario de Getafe (ICU) | Getafe, Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario Severo Ochoa (ICU) | Leganés, Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario Puerta de Hierro (ICU) | Majadahonda, Madrid, Spain | Not Yet Recruiting |
| Hospital Nuestra Señora del Prado (ICU) | Talavera de la Reina, Toledo, Spain | Not Yet Recruiting |
| Hospital Universitario de Cruces (Anesthesia) | Barakaldo, Vizcaya, Spain | Not Yet Recruiting |
| Hospital Universitario de Cruces (ICU) | Barakaldo, Vizcaya, Spain | Not Yet Recruiting |
| Hospital Universitario de A Coruña (ICU) | A Coruña, Spain | Not Yet Recruiting |
+ 28 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04545242