Corticosteroids for Inflammation in Heart Failure Cardiogenic Shock
This study, called CORTISHOCK-P, is looking at whether a short course of a steroid medication called methylprednisolone can help patients with heart failure-related cardiogenic shock. Cardiogenic shock happens when your heart can't pump enough blood to your body, often leading to severe inflammation. Researchers want to see if reducing this inflammation with methylprednisolone, given along with your usual medical care, is safe and helps you recover faster. You could be eligible if you are 18-80 years old, in the ICU with cardiogenic shock, and have signs of inflammation. The study will measure changes in a marker of inflammation (hsCRP) to see if the treatment is working. About 30 patients are planned for this study, and its current status is unclear.
- Study design
- This is a pilot study that will include about 30 participants. It is a randomized, open-label study, meaning participants will be randomly assigned to a treatment group, and both you and your doctors will know which treatment you are receiving.
- What's involved
- Participants will receive methylprednisolone intravenously for 7 days, starting with 80 mg daily for 3 days, followed by a tapering dose for 4 additional days. You will also receive routine medical care for your condition.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your inflammation levels will be measured at baseline, 24, 48, 72, and 96 hours, and at day 7 or when you leave the ICU.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock
At a glance
Conditions
NCT07461961
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Brigham and women's hospital
Boston, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in High-Sensitivity C-Reactive Protein (hsCRP) ConcentrationBaseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge
The primary outcome is the change in hsCRP concentration, which serves as a biomarker-based measure of systemic inflammation to evaluate corticosteroid-mediated inflammatory modulation. To account for the pharmacokinetics of methylprednisolone, a 12-hour blanking period will be imposed; clinical outcomes occurring within the first 12 hours after treatment initiation will not be considered in the analysis