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Dexamethasone / Acute Respiratory Distress Syndrome (ARDS) · Phase 3 Trial
ClinicalTrials.gov · September 2, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 trial registration (not yet reporting results) evaluating dexamethasone versus placebo for sepsis-associated acute respiratory distress syndrome, with 90-day all-cause mortality as the primary endpoint. The study is actively recruiting 1,704 participants across multiple centers and is designed to test whether glucocorticoids reduce mortality in a high-burden ARDS subtype. No efficacy or safety data are available from this registry record.
Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Acute Respiratory Distress Syndrome (ARDS). Intervention: Dexamethasone Group. Compared with: Placebo Group — Placebo Comparator. n = 1,704. 2 sites: China.
This is a Phase 3 trial registration (not yet reporting results) evaluating dexamethasone versus placebo for sepsis-associated acute respiratory distress syndrome, with 90-day all-cause mortality as the primary endpoint. The study is actively recruiting 1,704 participants across multiple centers and is designed to test whether glucocorticoids reduce mortality in a high-burden ARDS subtype. No efficacy or safety data are available from this registry record.
No efficacy, safety, or outcome data are available for assessment.
If dexamethasone is shown to reduce 90-day mortality in sepsis-associated ARDS, it would represent a significant advance in the supportive management of this high-mortality critical illness. Current practice lacks a proven pharmacologic mortality-reducing intervention in this population.
This is a Phase 3 trial registration with no results posted; the study is actively recruiting and has not yet reported outcomes, so no efficacy evidence exists to evaluate.
As stated by the source record.
Quoted from the source exactly as published.
If dexamethasone is shown to reduce 90-day mortality in sepsis-associated ARDS, it would represent a significant advance in the supportive management of this high-mortality critical illness. Current practice lacks a proven pharmacologic mortality-reducing intervention in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07576660). This is a study registration, not published results. Lead sponsor: Southeast University, China. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1704 participants (ESTIMATED). Conditions: Acute Respiratory Distress Syndrome (ARDS). Interventions: DRUG: Dexamethasone; DRUG: Placebo. Primary outcome measures: 90-day all-cause mortality , From randomization (day 0) to day 90 (inclusive). Brief summary: Acute respiratory distress syndrome (ARDS) is a major cause of acute hypoxemic respiratory failure in critically ill patients and is associated with substantial mortality. Current management is largely supportive, and no pharmacologic therapy has been shown consistently to reduce mortality in a broad population of patients with ARDS. Inflammation plays a central role in the pathogenesis of ARDS. Excessive inflammatory activation contributes to alveolar-capillary injury, impaired gas exchange, and progression of organ dysfunction. Glucocorticoids may mitigate these processes and have been associated in some studies with improved clinical outcomes, including shorter duration of mechanical ventilation. However, the effect of glucocorticoids on survival remains uncertain. ARDS is a heterogeneous syndrome with diverse etiologies, and treatment response may vary according to the underlying cause. A post hoc analysis of the Dex-ARDS trial suggested that the treatment effect of glucocorticoids may be greater in ARDS caused by pneumonia or extrapulmonary sepsis. In a cross-sectional survey of 135 patients with ARDS from 20 ICUs in China, pneumonia- and extrapulmonary sepsis-associated ARDS accounted for 77.6% of cases, indicating that these are the predominant etiologic subtypes encountered in clinical practice in China. More importantly, compared with ARDS attributable to other causes, pneumonia- and extrapulmonary sepsis-associated ARDS has been associated with higher mortality, suggesting a greater disease burden, worse prognosis, and a more urgent need for improved treatment strategies. On this basis, the present trial will enroll patients with ARDS caused by sepsis, including pneumonia and extrapulmonary sepsis. The primary hypothesis of this study is that, among patients with sepsis-associated ARDS, dexamethasone plus usual care, as compared with placebo plus usual care, will reduce 90-day all-cause mortality. We therefore designed a multicenter, randomized, double-blind, controlled trial to evaluate the clinical efficacy of dexamethasone in patients with sepsis-associated ARDS. The primary objective is to compare dexamethasone plus usual care with placebo plus usual care with respect to 90-day all-cause mortality.
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