Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock

NCT07603024 | Not Yet Recruiting

• 1 other identifier: 2026-ICU02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Keywords

Shenfu Injection; Traditional Chinese Medicine; Septic Shock; Vascular Waterfall Phenomenon; Critical Closure Pressure; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 hours after infusion

Secondary Outcomes (9)

• Change in Cardiac Index (CI)

  Baseline and 3 hours after infusion

• Change in Stroke Index (SI)

  Baseline and 3 hours after infusion

• Change in Systemic Vascular Resistance Index (RIs)

  Baseline and 3 hours after infusion.

• Change in Critical Closure Pressure (Pcc)

  Baseline and 3 hours after infusion.

• Change in Mean Systemic Filling Pressure (Pmsf)

  Baseline and 3 hours after infusion.

Study Arms (1)

Shenfu Injection Group

EXPERIMENTAL

All enrolled patients with septic shock will receive a single intravenous infusion of Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). The drug dose is 100 mL, diluted in 250 mL of normal saline, infused over 1 hour after initial hemodynamic stabilization. Hemodynamic and microcirculatory parameters are measured before infusion and 3 hours after infusion, including vascular waterfall difference (critical closure pressure minus mean systemic filling pressure) and related physiological variables. No control or placebo arm is included in this study.

Drug: Shenfu Injection

Interventions

Shenfu Injection DRUG

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.

Shenfu Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Severe pulmonary bullae, pneumothorax, or conditions precluding safe inspiratory hold maneuvers.
• Pregnancy or lactation. Expected ICU stay \< 48 hours or limitation of life-sustaining therapy. Known allergy or contraindication to Shenfu Injection or its ingredients (e.g., ginseng, aconitum).

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, 241001, China

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Shen-Fu

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)