Efficacy and Safety of Anisodamine Hydrobromide Combined with Low-molecular-weight Heparin for the Treatment of Sepsis Patients: Study Protocol for a Multicenter Randomized Controlled Trial

The objective of this study was to compare the effects of traditional treatment with those of anisodamine hydrobromide (Ani HBr) combined with low-molecular-weight heparin (LMWH) in the treatment of sepsis in hopes that this therapy will provide alternatives for the treatment of sepsis. This was a randomized, placebo-controlled, open-label, multicenter trial involving patients with sepsis recruited from seven emergency departments in Beijing, China. Patients diagnosed with sepsis will be randomly assigned to either the treatment or control group at a 1:1 ratio. The treatment group will receive Ani HBr combined with LMWH, while the control group will receive conventional treatment. A total of 782 sepsis patients will be recruited, and interim analysis will be conducted. The primary endpoint of the study was the 28-day mortality rate. The secondary endpoints included the lactate clearance rate at 6 hours, 24 hours, and 72 hours, the duration of ICU and hospital stay, the number of days without organ failure, the number of days with vasopressor use within 28 days, the septic shock conversion rate, the 28-day mortality rate of septic shock, and the 72-hour sublingual microcirculation. If the combination therapy of Ani HBr and LMWH demonstrates superior efficacy compared to conventional treatment, this study will provide valuable insights into the treatment of septic shock and potentially contribute to reducing the mortality rate associated with this condition. Trial registration: NCT05634057 (https://register.clinicaltrials.gov/).