Effectiveness and safety of Shenfu injection in septic patients with hypoperfusion:A multi-center,open-label,randomized,controlled trial

Background:To evaluate the effectiveness and safety of the Shenfu injection(SFI)combined with standard bundle treatment in septic patients with hypoperfusion.Method:This study was a multi-center,randomized,open-label,controlled trial conducted in four teaching hos-pitals in China.The septic patients with hypoperfusion and traditional Chinese medicine(TCM)syndrome with Yang-Qi deficiency were enrolled from January 2019,through September 2020.Eligible patients were randomly allocated in a 1:1 ratio to either receive 60 mL of SFI infusion per day plus standard treatment(SFI group)or stan-dard bundle treatment alone(control group).The primary outcome was 28-day all-cause mortality.Secondary outcomes were 90-day all-cause mortality time to weaning from mechanical ventilation,time to weaning from vasopressors,time to discharge from the ICU and hospital,and laboratory results after randomization.Results:A total of 188 patients completed the trail.This study revealed that the results of the SFI group and the control groups were not statistically significant in 28-day all-cause mortality(10.6%vs.20.2%,respectively;P=0.106).The infusion of SFI was associated with a significant reduction in the duration of vasopressor use(median=4.0 days,interquartile range[IQR]:2.0 days-6.0 days vs.median=5.0 days,IQR:3.0 days-8.0 days,respectively;P=0.043).Patients in the SFI group had statistically greater reductions in plasma lactate levels compared with those in the control group at the first 12 h(median=1.1 mmol/L,IQR:0.3-2.0 mmol/L vs.median=0.0 mmol/L,IQR:−0.2 to 0.8 mmol/L,respectively;P<0.001)and 24 h(median=1.4 mmol/L,IQR:0.3-2.2 mmol/L vs.median=0.4 mmol/L,IQR:−0.4 to 1.6 mmol/L,respectively;P=0.001).Conclusion:SFI plus standard therapy did not significantly decrease 28-day all-cause mortality for septic patients with hypoperfusion and TCM syndrome with Yang-Qi deficiency.