Early Intravenous Hydrocortisone in Sepsis: a Randomized Control Trial

What this Trial Is About

Researchers are studying the best timing for steroid treatment in patients with severe infections who develop low blood pressure, known as septic shock. The study compares starting low-dose hydrocortisone early after low blood pressure develops versus waiting until standard treatments to raise blood pressure do not work. The main goal is to see which timing improves survival and other health outcomes in adults with sepsis. Participants are randomly assigned to receive either early intravenous hydrocortisone or a placebo immediately after developing low blood pressure from infection. The early hydrocortisone group receives a bolus dose followed by a continuous infusion for two days. The control group receives a matching placebo infusion. If blood pressure goals are not met after initial treatment, both groups may receive open-label hydrocortisone according to current guidelines. Blood samples are collected to measure inflammatory markers and cortisol, and blood glucose is monitored regularly. During the study, participants will receive standard care for septic shock including antibiotics and organ support. Researchers will monitor survival up to 28 days and assess secondary outcomes such as time to shock control, hospital stay length, ventilator use, kidney support, and complications like infections or high blood sugar. Safety is closely monitored, with the ability to stop the study drug if harmful effects occur. The total participation includes treatment and follow-up for up to three months after hospitalization.

Early Intravenous Hydrocortisone in Sepsis