RecruitingPhase 2Drug trial
Corticosteroids in Hyperinflammatory Phenotype of Critical Illness
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