Shenfu Injection Modulates Carotid Elasticity in Septic Shock
Launched by FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE · Apr 4, 2025
Trial Information
Current as of July 09, 2025
Not yet recruiting
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).
About First Affiliated Hospital Of Wannan Medical College
The First Affiliated Hospital of Wannan Medical College is a leading medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. With a strong commitment to academic excellence and collaboration, the hospital serves as a pivotal research hub, facilitating a wide range of clinical trials aimed at improving patient outcomes and enhancing medical knowledge. Equipped with state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals, the hospital fosters an environment of rigorous scientific inquiry and ethical standards, ensuring the highest quality of care and research integrity.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wuhu, Anhui, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported