ORIGINAL RESEARCH article

Front. Pharmacol.

Sec. Ethnopharmacology

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

  • 1. Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

  • 2. Clinical Research Center of Hubei Critical Care Medicine, Wuhan, Hubei, China

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Abstract

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 hours 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].

Summary

Keywords

Myocardial injury biomarker, Sepsis, Sepsis-induced cardiomyopathy, septic shock, Shenfu injection

Received

08 August 2025

Accepted

16 February 2026

Copyright

© 2026 Liu, Fang, Zhou, Zhu, Wang and Hu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Jing Wang; Bo Hu

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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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