About this trial
This study focuses on improving heart function in patients with life-threatening blood infections (septic shock). When the body fights severe infections, the heart sometimes struggles to pump blood effectively, which can lead to dangerous complications. Current treatments like intravenous fluids and blood pressure medications have limitations in protecting heart function.
This multicenter clinical trial aims to evaluate whether adding Shenfu Injection - a traditional Chinese medicine preparation widely used to enhance cardiac function in cardiovascular diseases - to standard therapies can:
1. Prevent myocardial dysfunction during septic shock 2. Accelerate cardiac recovery if complications occur 3. Improve overall survival and clinical outcomes The randomized controlled design will compare therapeutic effects between two groups: one receiving standard septic shock treatment alone, and the other receiving standard treatment combined with Shenfu Injection.
Eligibility criteria
Qualifiers
1. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
2. Age ≥ 18 years.
Disqualifiers
1. Pregnant or breastfeeding women;
2. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components;
3. Severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, HIV, etc.;
4. Severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (New York Heart Association [NYHA] Class IV);
Trial design
Treatments tested in this trial
- Shenfu Injection
Treatment groups
Sponsors and collaborators
First Affiliated Hospital of Wannan Medical College
Lead sponsor
Suzhou Municipal Hospital of Anhui Province
Collaborator
the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China
Collaborator
Wuhu County Traditional Chinese Medicine Hospital
Collaborator
Wuhu first people's hospital
Collaborator
Wuhu City Second People's Hospital
Collaborator
Xuancheng People's Hospital
Collaborator
Tongling People's Hospital
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
The Fourth Affiliated Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
The Third People's Hospital of Bengbu
Collaborator
Fuyang people's hospital
Collaborator
Chaohu Hospital of Anhui Medical University
Collaborator
The First People's Hospital of Bengb
Collaborator
Guangde people's hospital
Collaborator
Fuyang Traditional Chinese Medicine Hospital
Collaborator
Taihe County Traditional Chinese Medicine Hospital
Collaborator