Hydrocortisone Treatment for Children With Septic Shock in Pediatric Intensive Care Units

What this Trial Is About

Researchers are evaluating the potential benefits and risks of using adjunctive hydrocortisone in children with septic shock that does not respond to fluids and vasoactive medications. The trial aims to determine whether hydrocortisone can reduce the occurrence of new or worsening organ dysfunction and improve outcomes such as survival and quality of life in pediatric patients. This study is a randomized, double-blinded, placebo-controlled trial involving critically ill children in pediatric intensive care units. Participants are randomly assigned to one of two groups one receives hydrocortisone sodium succinate according to a specific dosing schedule, and the other receives a placebo of normal saline with the same volume and schedule. The hydrocortisone treatment starts with a 2 mgkg intravenous bolus followed by 1 mgkg doses every six hours for up to seven days or until vasoactive medications have been stopped for at least 12 hours. The placebo group receives an identical schedule of saline infusions. During the study, children will be monitored closely while in the intensive care unit for adverse events such as high blood sugar, gastrointestinal bleeding, delirium, and hospital-acquired infections. Researchers will assess organ dysfunction using the Pediatric Logistic Organ Dysfunction PELOD-2 tool and evaluate health-related quality of life with the Pediatric Quality of Life Inventory PedsQL at 28 days after enrollment. Follow-up assessments will also occur at 90 days. The study plans to enroll up to 500 children from multiple countries, with the goal of improving treatment guidelines for septic shock in children.

Stress Hydrocortisone In Pediatric Septic Shock