The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College

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

440 Participants
are divided into 2 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