Shenfu Injection Modulates Carotid Elasticity in Septic Shock

Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether Shenfu Injection, a traditional Chinese herbal medicine, can help improve blood vessel health in patients experiencing septic shock, a serious condition that can occur due to infections. The main goal is to see if this treatment can make the carotid artery, a major blood vessel in the neck, more flexible. This flexibility might help patients recover better from septic shock.

To participate, you need to be an adult (18 years or older) diagnosed with septic shock and your doctor must plan to use Shenfu Injection as part of your treatment. However, individuals with certain serious heart or organ conditions, or those who are pregnant or breastfeeding, cannot join. During the study, participants will undergo safe and painless ultrasound scans to measure blood flow and artery movement before and after receiving the injection. Blood tests will also be performed to monitor inflammation and organ health. The study is designed to be voluntary, and you can choose to withdraw at any time without affecting your care. Your privacy will be protected, and all personal information will remain confidential.

Gender

ALL

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).