Corticosteroids in Hyperinflammatory Phenotype of Critical Illness (NCT07511582) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Corticosteroids in Hyperinflammatory Phenotype of Critical Illness
China150 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn whether methylprednisolone improves outcomes in critically ill patients with a hyperinflammatory phenotype. It will also evaluate the safety of methylprednisolone at different doses.
The main questions it aims to answer are:
* Does methylprednisolone improve organ function compared with placebo?
* Does methylprednisolone reduce the risk of mortality within 30 days?
Researchers will compare high-dose methylprednisolone (160mg/d), low-dose methylprednisolone (80mg/d), and placebo (normal saline) to evaluate effectiveness and safety.
Participants will:
* Receive high-dose methylprednisolone, low-dose methylprednisolone, or placebo every 12 hours for the first 3 days
* Be reassessed on Day 4 based on their inflammatory status If the hyperinflammatory phenotype persists, the treatment dose will be reduced by half and continued until Day 7 or ICU discharge, whichever occurs first If the patient transitions to a hypoinflammatory phenotype, the study treatment will be discontinued
* Be monitored daily in the intensive care unit for organ function, inflammatory status, and need for organ support
* Be followed for up to 30 days after randomization to assess survival and recovery
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years.
✓. Diagnosis of acute respiratory distress syndrome (ARDS) or sepsis.
✓. acute onset within 1 week of a known clinical insult or new/worsening respiratory symptoms;
✓. bilateral pulmonary opacities on chest imaging (X-ray or CT) or bilateral B-lines and/or consolidation on lung ultrasound, not fully explained by effusion, atelectasis, or nodules;
✓. respiratory failure not fully explained by cardiac failure or fluid overload;
✓. hypoxemia defined as PaO₂/FiO₂ ≤300 mmHg or SpO₂/FiO₂ ≤315 (with SpO₂ ≤97%) under a minimum positive end-expiratory pressure (PEEP) of 5 cmH₂O.
Exclusion criteria
✕. Requirement for high-dose vasopressor support, defined as norepinephrine ≥0.5 μg/kg/min or epinephrine ≥0.25 μg/kg/min.
✕. Post-cardiac surgery patients (e.g., coronary artery bypass grafting or valve replacement).
✕. Conditions requiring systemic corticosteroid therapy exceeding 1 mg/kg methylprednisolone or an equivalent dose (e.g., acute asthma exacerbation, acute exacerbation of chronic obstructive pulmonary disease, or autoimmune diseases).
What they're measuring
1
Proportion of patients with a decrease in mean Sequential Organ Failure Assessment (SOFA) score ≥1.4 points from baseline to Day 9