Not Yet RecruitingPhase 4

Shenfu Injection Modulates Carotid Elasticity in Septic Shock

China48 participantsStarted 2025-04-15

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Carotid Artery Circumferential Strain (CS)

Timeframe: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

Carotid Artery Elasticity (Beta (β)2 Stiffness Index)

Trial details

NCT IDNCT06915506

SponsorFirst Affiliated Hospital of Wannan Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Qiancheng Xu

86-18297529106 qianchengxu@wnmc.edu.cn

View on ClinicalTrials.gov More Septic Shock trials