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Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock
Sponsor: First Affiliated Hospital of Wannan Medical College
Summary
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.
Official title: Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-07-01
Completion Date
2027-06-30
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
Shenfu Injection
All 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.
Locations (1)
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, China