Shenfu Injection Modulates Carotid Elasticity in Septic Shock

NCT ID: NCT06915506

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Shenfu Injection Group

Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. Following completion of fluid resuscitation and confirmation of hemodynamic stability (maintained for ≥1 hour with vasoactive agents), Shenfu Injection will be administered at a dose of 60 mL via continuous infusion over 3 hours using a syringe pump. Carotid artery circumferential strain will be quantitatively assessed using ultrasound Speckle Tracking Imaging (STI) at the following five time points to evaluate carotid artery elasticity:

T0: Pre-administration baseline T1: 1 hour post-administration initiation T2: 2 hours post-administration initiation T3: 3 hours post-administration initiation (end of infusion) T4: 1 hour post-infusion completion

Group Type: EXPERIMENTAL

Shenfu Injection

Intervention Type: DRUG

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.

Control Group

Patients in this group will receive standard sepsis management strictly adhering to international and Chinese guidelines. Following completion of fluid resuscitation and confirmation of hemodynamic stability (defined as ≥1 hour of stable vasoactive agent requirements without dose escalation), carotid artery circumferential strain will be serially assessed using ultrasound speckle tracking imaging (STI) to evaluate vascular elasticity. Measurements will be performed at five predefined time points aligned with the intervention group's protocol:

T0: Baseline (immediately post-stabilization) T1: 1 hour post-T0 T2: 2 hours post-T0 T3: 3 hours post-T0 T4: 4 hours post-T0

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Diagnosis of sepsis or septic shock in the acute phase, as defined by the -Sepsis-3 criteria (confirmed infection with Sequential Organ Failure Assessment [SOFA] score ≥ 2 points above baseline).
• Voluntary participation with written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria

• Severe carotid atherosclerosis (e.g., carotid Intima-Media Thickness (IMT)>1.2 mm or confirmed plaque formation) diagnosed by prior imaging.
• Significant cardiovascular comorbidities that may confound hemodynamic assessments, including:
• Severe cardiomyopathy (e.g., ejection fraction <30%).
• Uncontrolled arrhythmias (e.g., ventricular tachycardia, atrial fibrillation with rapid ventricular response).
• Congenital heart disease with hemodynamic instability.
• Active hepatic or renal insufficiency (e.g., Child-Pugh class C, dialysis dependence) or advanced systemic diseases (e.g., metastatic malignancy, terminal illness).
• Poor ultrasound image quality precluding reliable speckle tracking analysis (e.g., inadequate acoustic window, motion artifacts).
• Pregnancy or lactation (due to potential hormonal influences on vascular physiology).
• Withdrawal from the study or inability to complete follow-up assessments (e.g., non-compliance, transfer to another facility).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhu City Second People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Qiancheng Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhu, Anhui, China

Countries

China

Central Contacts

Qiancheng Xu

Role: CONTACT

qianchengxu@wnmc.edu.cn

86-18297529106

Facility Contacts

Shengsheng Tao

Role: primary

taoshengsheng@yjsyy.com

86-18315329399

Other Identifiers

202506

Identifier Type: -

Identifier Source: org_study_id