Clinical trial NCT06898723: The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis
Official title: The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Septic Cardiomyopathy
Septic Shock
Keywords: Septic Shock
Cardiac Dysfunction
Shenfu Injection
Myocardial Protection
Randomized Controlled Trial
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
Collaborators: name: Suzhou Municipal Hospital of Anhui Province
name: the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China
name: Wuhu Hospital of Chinese Traditional Medicine
name: Wuhu first people's hospital
name: Wuhu City Second People's Hospital
name: Xuancheng people's hospital
name: Tongling People's Hospital
name: The Second Hospital of Anhui Medical University
name: The Fourth Affiliated Hospital of Anhui Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: The Third People's Hospital of Bengbu
name: Fuyang people's hospital
name: Chaohu Hospital of Anhui Medical University
name: The First People's Hospital of Bengb
name: Guangde people's hospital
name: Fuyang Traditional Chinese Medicine Hospital
name: Taihe County Traditional Chinese Medicine Hospital
First posted: 2025-03-27
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 1. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
* 2. Age ≥ 18 years.

Exclusion Criteria:

* 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);
* 5. Any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma;
* 6. Use of Ginseng and Aconite Injection for less than 48 hours;
* 7. Patients expected to die within 48 hours;
* 8. Patients deemed unsuitable for this study by the investigator.

Primary outcomes:
measure: The incidence of septic cardiomyopathy
timeFrame: Day 7
measure: Duration of vasopressor administration
timeFrame: 28 days
Secondary outcomes:
measure: The incidence of septic cardiomyopathy
timeFrame: Day 3
measure: Improvement in Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 3
measure: Improvement in Sequential Organ Failure Assessment (SOFA) Score
timeFrame: Day 7
measure: Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)
timeFrame: 3 days
measure: Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)
timeFrame: 7 days
measure: Duration of mechanical ventilation
timeFrame: 28 days
measure: Length of Intensive Care Unit(ICU) stay
timeFrame: 28 days
measure: Length of hospital stay
timeFrame: 28 days
measure: 28-day mortality rate
timeFrame: 28 days
measure: 7-day mortality rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
state: Anhui
Study officials:
References: