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

Abstract

Background Septic acute gastrointestinal injury (S-AGI) plays a vital role in the initiation and worsening of sepsis. Electro-acupuncture (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 control trial at a single center has been designed to thoroughly assess the efficacy and safety of EA as an adjunctive therapy to prevent the incidence of S-AGI for patients with Sepsis. Methods 200 mechanically ventilated patients who are aged over 18 years old with a clinical diagnosis of sepsis will be recruited in Guangdong Provincial Hospital of Chinese Medicine in China. Patients will be randomly assigned, in a 1:1 ratio, to the EA group and control group. All patients in the control group will receive conventional drug therapy for S-AGI, while patients in the EA group will receive the combination of EA and conventional drug therapy. Only blood test assessors, and statisticians will be blinded to the group assignment. The primary outcome will be the incidence of S-AGI at day 10. The secondary outcomes will be severity grading of S-AGI, gastric retention, abdominal circumference, intra-abdominal pressure, the frequency of bowel sounds, number of days tolerating daily feeding target, proportion of patients taking erythromycin and/or metoclopramide due to feeding intolerance, number of patients receiving one or more rectal laxatives due to constipation, plasma pre-albumin levels, incidence rate of the persistent inflammation, immunosuppression and catabolism Syndrome (PICS), number of days on invasive mechanical ventilation, the intensive care unit (ICU) length of stay, 7-day mortality rate, 28-day mortality rate and adverse events. Discussion The results of this research will provide substantial evidence regarding the efficacy of electro acupuncture in preventing S-AGI in patients with sepsis. Trial registration This study was approved by the Ethics Committee of the Guangdong Provincial Hospital of Chinese Medicine (approval number: BF2023-228-01) with registration at Chinese Clinical Trial Registry (identifier: ChiCTR2300078141) on December 29, 2023.