Early administration of shenfu injection for the incidence of sepsis-induced cardiomyopathy in septic patients: a randomized controlled trial

Background: Sepsis-induced cardiomyopathy (SIC) is a severe complication of sepsis that markedly increases mortality. Owing to its complex pathogenesis, no targeted drugs for SIC is currently available, highlighting the need for preventive interventions. This study aimed to evaluate whether early administration of Shenfu Injection (SFI) could prevent SIC. Methods: Patients diagnosed with sepsis 3.0 upon intensive care unit (ICU) admission but without SIC were randomly assigned to either the SFI group or control group via envelope randomization. The SFI group received intravenous SFI (200 mL/day) in addition to standard sepsis or septic shock management for 7 days (minimum 72 h if discontinued due to ICU transfer or death). The control group received an equivalent volume of saline alongside standard care. The primary outcome was the incidence of SIC within 7 days. Results: A total of 152 patients (76 per group) were analyzed. The incidence of SIC within 7 days was 9.2% in both groups. In the generalized linear mixed model (GLMM) adjusted for gender, age, septic shock and the baseline value of N-terminal pro-B-type natriuretic peptide (NT-proBNP), the interaction between time and group had a significant effect on NT-proBNP levels (P = 0.004). No significant differences were observed between groups in hemodynamic parameters, immune inflammatory indicators, organ function, vasoactive drug use, 7-day fluid balance, 28-day mortality, duration of mechanical ventilation, continuous renal replacement therapy duration, ICU stay, or total hospital stay. Conclusion: Early application of SFI did not significantly reduce the incidence of SIC in ICU patients with sepsis. Clinical Trial Registration: [https://www.chictr.org.cn/], identifier [ChiCTR2400088766].