The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study
| Registry | NCT06898723, acronym SHIELD Trail |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 440 (Estimated) |
| Sponsor | First Affiliated Hospital of Wannan Medical College (Other); collaborators: Suzhou Municipal Hospital of Anhui Province, the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, Wuhu County Traditional Chinese Medicine Hospital, Wuhu first people's hospital, Wuhu City Second People's Hospital, Xuancheng People's Hospital, Tongling People's Hospital, The Second Hospital of Anhui Medical University, The Fourth Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui Medical University, The Third People's Hospital of Bengbu, Fuyang people's hospital, Chaohu Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, Guangde people's hospital, Fuyang Traditional Chinese Medicine Hospital, Taihe County Traditional Chinese Medicine Hospital |
| Conditions | Septic Cardiomyopathy, Septic Shock |
| Interventions | Shenfu Injection (Drug) |
| Dates | start 2024-10-01, primary completion 2026-09-30 (estimated), completion 2026-09-30 (estimated), first posted 2025-03-27, last updated 2025-03-27 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Septic Cardiomyopathy All trials for Septic Shock All trials of Shenfu Injection
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Shenfu Injection Group | Experimental | Drug: Shenfu Injection | 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 |
| Control Group | No intervention | Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) | Wuhu, Anhui | China | Recruiting |