NCT06915506

Shenfu Injection Modulates Carotid Elasticity in Septic Shock

The Effect of Shenfu Injection on Carotid Artery Elasticity in Septic Shock Patients: A Prospective Observational Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

What is this study about? We are studying whether Shenfu Injection (a traditional Chinese herbal medicine) can help improve blood vessel health in patients with septic shock-a severe complication of infections that can damage blood vessels and organs. Specifically, we want to see if this treatment makes the carotid artery (a major neck blood vessel) more flexible and resilient, which may support recovery. Who can join? Adults (18 years or older) diagnosed with septic shock by their doctors. Patients whose doctors plan to use Shenfu Injection as part of their treatment. Patients who agree to participate and sign a consent form. Who cannot join? Patients with severe heart conditions, advanced organ failure, or major neck artery disease. Pregnant or breastfeeding women. Those unable to complete the study procedures. What will happen during the study? Safe and Pain-Free Tests: Ultrasound scans: A non-invasive imaging method will be used to measure the flexibility and blood flow of your neck artery. Advanced imaging technology: A special ultrasound technique (called speckle tracking) will take detailed pictures of your artery's movement during heartbeat cycles. Timing of Tests: Scans will be done before receiving Shenfu Injection and 1, 2, 3 hours after the injection, plus 1 hour after treatment ends. Other Data Collection: Blood tests to check inflammation and organ function. Recording your health status (e.g., blood pressure, heart rate) and recovery progress (e.g., time in the Intensive Care Unit (ICU), survival rates). What are the benefits and risks? Benefits: This study may help doctors better understand how Shenfu Injection works and improve future care for septic shock patients. Risks: The ultrasound scans are routine, safe, and painless. There is no extra risk beyond standard hospital care. Your Rights and Safety Voluntary Participation: You can withdraw at any time without affecting your treatment. Ethical Approval: This study is reviewed and approved by the hospital's ethics committee. Privacy: Your personal information and test results will be kept confidential.

Conditions

• Septic Shock
• Vascular Dysfunction
• Arterial Stiffness
• Carotid Artery Elasticity Alterations
• Sepsis

Interventions

Type	Name	Description
DRUG	Shenfu Injection	This intervention combines traditional Chinese medicine (TCM) with modern critical care practices to distinguish it from conventional sepsis therapies. Key unique features include: TCM-Based Intervention: Shenfu Injection: A standardized herbal extract derived from Panax ginseng and Aconitum carmichaelii , prepared under Chinese Pharmacopoeia guidelines. Mechanism: Targets mitochondrial dysfunction and endothelial glycocalyx repair, with preclinical evidence of anti-inflammatory, anti-apoptotic, and vasoregulatory effects. Precision Delivery Protocol: Dosage: 60 mL (1 mL/kg for patients \<60 kg) administered via syringe pump-controlled continuous infusion over 3 hours, ensuring stable plasma concentrations. Timing: Initiated only after hemodynamic stabilization (≥1 hour of stable vasopressor requirements post-fluid resuscitation), aligning with the "golden window" for vascular repair in sepsis.

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: China