The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis (SHIELD Trail)

First Affiliated Hospital of Wannan Medical College

Status and phase: Enrolling; Phase 4

Conditions: Septic Cardiomyopathy; Septic Shock

Treatments: Drug: Shenfu Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06898723

2024109

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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440 participants in 2 patient groups

Shenfu Injection Group

Experimental group

Description:

Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. On this basis, Shenfu Injection will be administered at a dosage of 50-100 ml (according to the medication practices of each participating center), diluted with an equal volume of 5% glucose and infused intravenously twice a day

Treatment:

Drug: Shenfu Injection

Control Group

No Intervention group

Description:

Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.