Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions

Recruiting now · Phase 4

Conditions studied: Acute Hypoxemic Respiratory Failure

In brief

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.

Key facts

Study ID

NCT04545242

Run by

Hospital Universitario de Gran Canaria Doctor Negrín

People needed

980

Starts

2021-07-06

Expected to finish

2026-12-30

Last updated by the study team

2025-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 18 years or older;
• intubated and mechanically ventilated;
• acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
• Pulmonary or systemic infectious etiology of AHRF.

You may not qualify if…

• Patients with a known contraindication to corticosteroids,
• Patient included in another therapeutic clinical trial
• Lack of informed consent

Where it is running

• Hospital Clínic de Barcelona (Anesthesia) — Barcelona, Spain (enrolling)
• Hospital Universitario La Paz (ICU) — Madrid, Spain (enrolling)
• Hospital Universitario Río Hortega (ICU) — Valladolid, Spain (enrolling)
• Hospital Clinico Universitario de Valencia (ICU) — Valencia, Spain (enrolling)
• 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 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

Full record on ClinicalTrials.gov

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