Composite adverse events compared early versus conventional cessation of hydrocortisone in patients with septic shock: Randomized-controlled trial (The CESSHYDRO study)

Abstract

Background: Intravenous hydrocortisone has benefits in the treatment of septic shock patients, but there are adverse events mentioned in the secondary outcomes of several studies, such as hyperglycemia, hypernatremia, secondary infection, and muscle weakness. In addition, there are no recommendations regarding the precise duration and steps to discontinue hydrocortisone administration. The CESSHYDRO trial evaluates the adverse outcomes of intravenous hydrocortisone between early cessation versus conventional cessation of hydrocortisone in septic shock patients. Methods: The CESSHYDRO trial is a single-center, double-blind, randomized controlled clinical trial conducted at Siriraj Hospital. One hundred and eighty septic shock patients receiving vasopressors and hydrocortisone at least 200 mg/day with hemodynamic stability will be included. The patients are randomized into 2 groups: intervention A (early cessation of hydrocortisone) and intervention B (conventional cessation). The primary outcomes were composite adverse events, including hyperglycemia, hypernatremia, muscle weakness, and new infections. Hypothesis: We hypothesize that early cessation of hydrocortisone in patients with septic shock would reduce composite adverse events including hyperglycemia, hypernatremia, muscle weakness, and the new onset of infection. Ethics and dissemination: The trial receives ethical approval from Siriraj Hospital, Mahidol University (COA No.SI012/2023). Trial registration: ClinicalTrials.govNCT05818826. Registered on April 19, 2023.