Status:
NOT_YET_RECRUITING
Shenfu Injection Modulates Carotid Elasticity in Septic Shock
Lead Sponsor:
First Affiliated Hospital of Wannan Medical College
Collaborating Sponsors:
Wuhu City Second People's Hospital
Conditions:
Septic Shock
Vascular Dysfunction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 i...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06915506
Start Date
April 15 2025
End Date
April 30 2026
Last Update
April 8 2025
Active Locations (1)
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1
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, China, 241000