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Studies

Interventional Recruiting Phase 4

NCT04545242 on ClinicalTrials.gov

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

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)

  • Sponsor: Dr. Negrin University Hospital
  • Collaborators: Li Ka Shing Knowledge Institute, Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • Enrollment: 980 (Estimated)
  • Study start: 2021-07-06 (Actual)
  • Primary completion: 2026-12-30 (Estimated)
  • Study completion: 2026-12-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Multicenter, randomized, controlled, open-label trial involving mechanically ventilated adult patients with AHRF (including ARDS) caused by confirmed bacterial or viral infections.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Acute Hypoxemic Respiratory Failure

Intervention / Treatment

  • Drug: Dexamethasone

Primary Outcome Measures

  • 60-day mortality (60 days)
    All-cause mortality at 60 days after randomization

Countries

Spain

Locations and Investigators

  • Hospital Clinico San Carlos, Madrid, Spain
    • María Paloma, González Arenas
  • Fundacio Assistencial De Mutua De Terrassa Fpc, Terrassa, Spain
    • Josep, Trenado Álvarez
  • Hospital Clinic De Barcelona, Barcelona, Spain
    • Carlos, Ortolá
  • Hospital Virgen De La Luz, Cuenca, Spain
    • Maury Valentina, Morales Ortiz
  • Hospital Universitario Regional De Malaga, Malaga, Spain
    • Juan Miguel, Mora Ordóñez
  • Hospital Clinico Universitario De Valencia, Valencia, Spain
    • José, Ferreres Franco
  • Clinica Universidad De Navarra, Pamplona, Spain
    • Pablo, Monedero
  • Hospital Universitario Ramon Y Cajal, Madrid, Spain
    • Diego, Gil Mayo
  • Hospital Universitario La Paz, Madrid, Spain
  • Hospital Universitario Rio Hortega, Valladolid, Spain
    • María Lorena, Fernández Rodríguez
  • Complexo Hospitalario Universitario De Pontevedra, Pontevedra, Spain
    • Marina, Varela Durán

Study Officials

  • Jesús Villar, MD (Principal Investigator) — Hospital Universitario Dr. Negrin