Ketogenic diet strategy in patients with sepsis: a multicentre prospective randomised interventional trial protocol

Sepsis is defined as a dysregulated host response to infection, associated with high morbidity and mortality rates globally. Recent studies have indicated that increasing ketone levels may be beneficial for patients with sepsis. Existing research has established the feasibility, effectiveness and safety of the ketogenic diet in sepsis patients. This study aims to further clarify the organ-protective effects of a ketogenic diet in sepsis patients through a multicentre randomised controlled trial.

This is a multicentre, prospective, randomised controlled trial conducted in five intensive care units (ICUs) in China. The intervention group will receive a ketogenic diet, while the control group will receive standard enteral nutrition. The primary outcome is the protective effect of the ketogenic diet on the heart, kidneys and liver in septic patients. Secondary outcomes include ICU and hospital mortality rate, ICU and hospital length of stay, rate and duration of mechanical ventilation, blood glucose levels and the rate of renal replacement therapy.

This study has been approved by the Ethics Committee of Northern Jiangsu People's Hospital Affiliated to Yangzhou University (No. 2024ky290-2). Upon completion, the researchers will disseminate the results to the public through publication in peer-reviewed journals TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry in December 2024 (Registration Number: ChiCTR2400093805).