What question did this study set out to answer?

To assess the effects of early Shenfu injection on hemodynamics and clinical outcomes in patients with sepsis.

July 17, 2026Critical Care Medicine0 citations

Effect of Early Administration of Shenfu Injection on Hemodynamics in Septic Patients: A Multicenter, Randomized, Controlled Trial

YXYangmei XiongWuhan University DZDongsu ZhangWuhan University HDHui DongWuhan Third Hospital

Key Points

To assess the effects of early Shenfu injection on hemodynamics and clinical outcomes in patients with sepsis.
Prospective, multicenter randomized controlled trial conducted in four tertiary care hospitals in central China.
172 ICU patients aged 18–75 who met Sepsis-3 criteria were randomized to receive either Shenfu injection or normal saline.
Intervention duration was 5 hours at a rate of 20 mL/hr for 3 consecutive days.
The SFI group required similar total norepinephrine equivalents (22.00 [16.00–29.50] vs. 20.00 [12.50–28.50]; p = 0.16].
Mortality during ICU stay was lower in the SFI group (3.5% vs. 11.6%; p = 0.04) and at 28 days (15.1% vs. 27.9%; p = 0.04).
Improved sublingual microcirculation indicators were observed in the SFI group compared to controls.

Abstract

Objectives: To evaluate the effect of early administration of Shenfu injection (SFI) on hemodynamics and clinical outcomes in ICU patients with sepsis. Design: Prospective, multicenter randomized controlled trial. Setting: Four tertiary care hospitals located in central China. Patients: ICU patients 18–75 years old who met the Sepsis-3 diagnostic criteria. Interventions: Eligible septic patients were randomized to the SFI group or the control group, receiving either SFI or normal saline at a rate of 20 mL/hr in 5 hours from the time of sepsis diagnosis, bid for 3 consecutive days. Measurements and Main Results: The primary outcome was the amount of vasopressors administration (calculated as the norepinephrine equivalents NEEs). A total of 172 patients were enrolled, with 86 assigned to the SFI group and 86 to the control group. Compared with the control group, the SFI group had no significant improvement in total NEE doses (22.00 16.00–29.50 vs. 20.00 12.50–28.50; p = 0.16). However, compared with the control group, the SFI group showed significantly lower mortality both during ICU stay (3.5% vs. 11.6%; p = 0.04) and 28 days after treatment (15.1% vs. 27.9%; p = 0.04). The SFI group also exhibited a significant improvement in sublingual microcirculation indicators compared with control group. No significant drug-related adverse events were noted in either group. Conclusions: The early administration of SFI did not decrease the dosage of vasopressors. The secondary outcomes suggested a potential decrease in mortality and possible improvement in microcirculation, findings that require further validation.

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