Electroacupuncture for the prevention of acute gastrointestinal injury in patients with sepsis undergoing mechanical ventilation (EAGISM): a protocol for an open-label randomized controlled trial

Background: Septic acute gastrointestinal injury (S-AGI) plays a vital role in the initiation and progression of sepsis. Electroacupuncture (EA) is utilized for the treatment and prevention of S-AGI due to its positive impact on gastrointestinal function. However, there is a lack of rigorous trials examining the effectiveness and safety of EA in this context. Thus, a randomized controlled trial (RCT) at a single center has been designed to thoroughly assess the efficacy and safety of EA as an adjunctive therapy for preventing the incidence of S-AGI in patients with sepsis. Methods: A total of 200 mechanically ventilated patients aged ≥18 years with a clinical diagnosis of sepsis will be recruited from the Guangdong Provincial Hospital of Chinese Medicine in China. Patients will be randomly assigned in a 1:1 ratio to either the EA group or the control group. All patients in the control group will receive conventional drug therapy for S-AGI, while patients in the EA group will receive a combination of EA and conventional drug therapy. Only blood test assessors and statisticians will be blinded to the group assignment. The primary outcome is the incidence of S-AGI at day 10. Secondary outcomes include the severity grading of S-AGI, gastric retention, abdominal circumference, intra-abdominal pressure, frequency of bowel sounds, number of days tolerating the daily feeding target, proportion of patients receiving erythromycin and/or metoclopramide due to feeding intolerance, number of patients receiving one or more rectal laxatives due to constipation, plasma prealbumin levels, incidence rate of persistent inflammation, immunosuppression, and catabolism syndrome (PICS), number of days on invasive mechanical ventilation, length of stay in the intensive care unit (ICU), 7-day mortality rate, 28-day mortality rate, and adverse events (AEs). Discussion: The results of this study will provide substantial evidence regarding the efficacy of electroacupuncture in preventing S-AGI in patients with sepsis. Clinical trial registration: http://www.chictr.org.cn, Identifier ChiCTR2300078141.