Electroacupuncture as Adjunctive Therapy for Organ Dysfunction Among Chinese ICU Patients with Sepsis: Study Protocol for a Randomized Clinical Trial

BACKGROUND: Sepsis is a dysregulated response of the host to infection that can lead to life-threatening organ dysfunction and remains a leading cause of mortality. Early recovery of impaired organ function is crucial for the outcomes of sepsis. Electroacupuncture (EA) is a promising adjunctive therapy for sepsis, but no study has focused on the efficacy of EA for organ dysfunction. This study aimed to investigate the efficacy and safety of EA in improving organ dysfunction among intensive care unit (ICU) patients with sepsis. METHODS: In this single-center, randomized, sham-controlled clinical trial, an adaptive sample size of 154-500 patients diagnosed with sepsis will be included. Eligible patients will be randomly assigned to receive EA or sham EA treatment at a 1:1 ratio using block randomization. Patients in the two groups will receive 6 consecutive sessions of 30-min EA or sham EA treatment, with the initial acupuncture treatment being completed within 24 h after randomization. The primary outcome is the change in the total score of the Sepsis-Related Sequential Organ Failure Assessment (SOFA) on day 7 after randomization compared with baseline. Secondary outcomes include changes in the SOFA score and related serological outcomes, mortality, ICU-free days, hospital-free days and organ support-free days from baseline to day 28. Statistical analyses will be performed on a full analysis set (FAS) and a per-protocol set (PPS). DISCUSSION: We expect the findings of this trial to provide evidence that the use of EA as an adjunctive therapy to ICU treatment can promote the recovery of organ function and other outcomes in sepsis patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06666946. Registered on 28 October 2024.