The effect of Xuanbai Chengqi decoction on patients with pneumonia-derived sepsis: study protocol for a randomized controlled trial

AbstractBackground: Sepsis and septic shock are major healthcare problems. pneumonia-derived is one of the important aspects of sepsis. The theory of traditional Chinese medicine (TCM) dictates that diseases of the lung and those of the large intestine react with each other. Methods/Design: A single-blind, randomised controlled clinical trial will be conducted involving 90 patients with pneumonia-derived sepsis. Participants will be randomised at a 1:1 ratio to receive Xuanbai Chengqi decoction (XCD) (experimental arm) or the same amount of saline treatment (control arm). The intervention will comprise one session/day for 1 week. The primary outcomes will be 28-day mortality, and levels of pro-inflammatory cytokines in bronchoalveolar lavage fluid and serum and static lung compliance, dynamic lung compliance, plateau pressure, and peak airway pressure, 1, 3 and 7 days after treatment completion with respect to baseline levels. Secondary outcomes will be the symptom score of traditional Chinese medicine, duration of parenteral nutrition, prevalence of complications and the course of antibiotic use. Measurements will be taken at baseline, 1, 3 and 7 days during the intervention, after 28 days after completing the intervention. Adverse events between arms will be evaluated. Discussion: This is the first trial to evaluate the effects of XCD on management of pneumonia-derived sepsis. If the results are as expected, they will provide evidence of XCD in promoting the results in pneumonia-derived sepsis patients. Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900024072. Registered on 24 June 2019.