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

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.