NCT06898723 The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis
| NCT ID | NCT06898723 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital of Wannan Medical College |
| Condition | Septic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 440 participants in total. It began in 2024-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06898723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06898723 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06898723 currently recruiting?
Yes, NCT06898723 is actively recruiting participants. Contact the research team at qianchengxu@wnmc.edu.cn for enrollment information.
Where is the NCT06898723 trial being conducted?
This trial is being conducted at Wuhu, China.
Who is sponsoring the NCT06898723 clinical trial?
NCT06898723 is sponsored by First Affiliated Hospital of Wannan Medical College. The trial plans to enroll 440 participants.