Corticosteroids in Hyperinflammatory Phenotype of Critical Illness
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBin Du
About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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).
Long-term systemic corticosteroid use within the past 6 months.
Trial design
Treatments tested in this trial
- Methylprednisolone (MP)
- Methylprednisolone (MP)
- Placebo
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Bin Du
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
Source ClinicalTrials.gov