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

Abstract

BackgroundTo evaluate the effectiveness and safety of the Shenfu injection (SFI) combined with standard bundle treatment in septic patients with hypoperfusion. MethodThis study was a multi-center, randomized, open-label, controlled trial conducted in four teaching hospitals in China. A total of 188 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 standard bundle treatment alone (control group). The primary outcome was 28-day all-cause mortality. Secondary outcomes were 90-day all-cause mortality and laboratory results after randomization. ResultsThis study revealed that the results of the SFI group and the control groups were not statistically significant in 28-day 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, interquartile range [IQR]: 2–6 vs. median=5, IQR: 3–8, 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, IQR: 0.3–2.0 vs. median=0.0, IQR: −0.2 to 0.8, respectively; P <0.001) and 24 h (median=1.4, IQR: 0.3–2.2 vs. median=0.4, IQR: −0.4 to 1.6, respectively; P=0.001). ConclusionSFI plus standard therapy did not significantly decrease 28-day all-cause mortality for septic patients with hypoperfusion and TCM syndrome with Yang-Qi deficiency.Trial registration Chinese Clinical Trial Registry Identifier: ChiCTR1800020435