NCT04545242 Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
| NCT ID | NCT04545242 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dr. Negrin University Hospital |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 980 participants |
| Start Date | 2021-07-06 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 980 participants in total. It began in 2021-07-06 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with a known contraindication to corticosteroids, * Patient included in another therapeutic clinical trial * Lack of informed consent
Contact & Investigator
Jesús Villar, MD
PRINCIPAL INVESTIGATOR
Hospital Universitario Dr. Negrin
Frequently Asked Questions
Who can join the NCT04545242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04545242 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04545242 currently recruiting?
Yes, NCT04545242 is actively recruiting participants. Contact the research team at jesus.villar54@gmail.com for enrollment information.
Where is the NCT04545242 trial being conducted?
This trial is being conducted at Terrassa, Spain, Alcázar de San Juan, Spain, Santiago de Compostela, Spain, Ponferrada, Spain and 11 additional locations.
Who is sponsoring the NCT04545242 clinical trial?
NCT04545242 is sponsored by Dr. Negrin University Hospital. The principal investigator is Jesús Villar, MD at Hospital Universitario Dr. Negrin. The trial plans to enroll 980 participants.