Effect of Shenfu Injection in Septic Patients with Hypoperfusion: A Multi-center, Open-label, Randomized, Controlled Trial

Background: The aim of our study was to evaluate the effectiveness and safety of Shenfu injection (SFI) combined with standard bundle in septic patients with hypoperfusion. Method: This study was a multi-center, randomized, open-label, controlled trial conducted in four teaching hospitals in China. 188 septic patients with hypoperfusion who were diagnosed as the acute deficiency syndrome depending on the traditional Chinese medicine criteria were enrolled from January 2019 through September 2020. Eligible patients were randomly allocated in a 1:1 ratio to either the treatment group, receiving 60 mL SFI infusion per day plus standard treatment, or the control group, receiving standard bundle treatment alone. Results: In this study, we found that SFI plus standard therapy did not significantly decrease 28-day all-cause mortality of septic patients with hypoperfusion and TCM syndrome meeting the acute deficiency syndrome. The infusion of SFI was associated with a significant reduction in the duration of vasopressor use. Patients in the SFI group had statistically greater reductions in plasma lactate levels at the first 12 and 24 hours. Conclusion: SFI plus standard therapy did not significantly decrease 28-day all-cause mortality for septic patients with hypoperfusion when the TCM syndrome meets the acute deficiency syndrome. SFI can shorten the use time of vasoactive drugs and promote the recovery of lactic acid level in septic patients with hypoperfusion. Trial registration: This trial was approved by the Ruijin Hospital Ethics Committee of Shanghai Jiaotong University School of Medicine and was registered in Chinese Clinical Trial Registry. Trial registration: ChiCTR Registration number: ChiCTR1800020435 Date of first trial registration: 29/12/2018 Website: http://www.chictr.org.cn/showproj.html?proj=34499