This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation.
Eligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure.
This study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.
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Single group
Shenfu Injection
DrugAll participants in the study will receive a single intravenous infusion of Shenfu Injection, a traditional Chinese medicine produced by China Resources Sanjiu Pharmaceutical Co., Ltd. The injection contains extracts of Ginseng Radix et Rhizoma and Aconiti Lateralis Radix Praeparata. Each dose consists of 100 mL Shenfu Injection, diluted in 250 mL normal saline, and administered through continuous intravenous infusion over 1 hour after initial hemodynamic stabilization according to Surviving Sepsis Campaign guidelines. Hemodynamic measurements will be performed before infusion (within 30 minutes) and at 3 hours after infusion. Variables include critical closure pressure (Pcc), mean systemic filling pressure (Pmsf), cardiac index, systemic vascular resistance, central venous oxygen saturation, arterial-venous CO₂ difference, and blood lactate concentration. No other investigational drugs, placebos, or control interventions are administered in this study.
Change in vascular waterfall difference (Critical Closure Pressure [Pcc] - Mean Systemic Filling Pressure [Pmsf])
The difference between Pcc and Pmsf (in mmHg) measured via ventilator-induced inspiratory hold method during mechanical ventilation, representing presence and magnitude of vascular waterfall phenomenon.
Change in Cardiac Index (CI)
Cardiac index (L/min/m²) represents cardiac output standardized by body surface area and indicates overall pump function. CI will be measured continuously using the PiCCO hemodynamic monitoring system through arterial thermodilution. Values before Shenfu Injection and 3 hours post-infusion will be compared to evaluate changes in cardiac performance.
Change in Stroke Index (SI)
Stroke index (mL/m²) reflects the amount of blood ejected from the left ventricle per beat per body-surface area, used to assess stroke volume changes. Measured using the PiCCO system and calculated automatically from thermodilution data.
Change in Systemic Vascular Resistance Index (RIs)
Calculated as (MAP - CVP)/CI (unit: mmHg · min · m²/L).
Change in Critical Closure Pressure (Pcc)
Pcc (mmHg) is obtained by plotting ventricular output against mean arterial pressure during ventilator inspiratory hold maneuvers. It represents the pressure below which small vessels collapse and microcirculatory flow ceases. Analyzing Pcc before and after infusion will help assess whether Shenfu Injection modifies microvascular closing pressure.
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