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

Study acronym: DEXA-REFINE
StatusCompleted
PhasePhase 4
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Dec 30, 2026 to Dec 30, 2020
    • Start date: Jul 6, 2021 to Jul 6, 2020
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 40 of 40 sites
    • Publications: details revised at 2 of 2 entries
  2. Primary and study completion dates: Dec 30, 2024 to Dec 30, 2026v7
  3. Primary and study completion dates: Dec 30, 2023 to Dec 30, 2024v6
  4. Primary completion date: Sep 30, 2023 to Dec 30, 2023v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 8, 2021 to Jul 6, 2021
    • Site details revised at 40 of 40 sites
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Oct 7, 2020 to Feb 8, 2021
    • Site contacts updated at 4 of 40 sites
    v3
  2. Study Identification, Study Statusv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04545242
Lead Sponsor Hospital Universitario de Gran Canaria Doctor Negrín
Collaborators: Li Ka Shing Knowledge Institute, Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions
(from sponsor)		 Acute Hypoxemic Respiratory Failure
Related terms Infections, Respiratory Insufficiency
Enrollment 980 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov