The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- The incidence of septic cardiomyopathy
研究概览
简要总结
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:
- Prevent myocardial dysfunction during septic shock
- Accelerate cardiac recovery if complications occur
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
In this clinical trial, in addition to the ultrasound assessors mentioned above, other members of the research team, including data analysts and study coordinators, will also be masked. These individuals will not have access to specific group assignment information during the trial to ensure the objectivity of data analysis and the reliability of the results. Furthermore, participants and their immediate family members will be informed about the basic aspects of the trial but will not be disclosed the specific treatment group assignments to minimize potential bias and influence. All randomization information will be managed by an independent randomization center to ensure the integrity of the masking process.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
- •Age ≥ 18 years.
排除标准
- •Pregnant or breastfeeding women;
- •Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components;
- •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.;
- •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);
- •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;
- •Use of Ginseng and Aconite Injection for less than 48 hours;
- •Patients expected to die within 48 hours;
- •Patients deemed unsuitable for this study by the investigator.
研究组 & 干预措施
Shenfu Injection Group
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
干预措施: Shenfu Injection (Drug)
结局指标
主要结局
The incidence of septic cardiomyopathy
时间窗: Day 7
Duration of vasopressor administration
时间窗: 28 days
The duration of vasopressor administration refers to the total time a patient requires vasopressor medications, measured in hours or days, to maintain blood pressure and support circulation.
次要结局
- The incidence of septic cardiomyopathy(Day 3)
- Improvement in Sequential Organ Failure Assessment (SOFA) score(Day 3)
- Improvement in Sequential Organ Failure Assessment (SOFA) Score(Day 7)
- Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)(7 days)
- Duration of mechanical ventilation(28 days)
- Length of Intensive Care Unit(ICU) stay(28 days)
- Length of hospital stay(28 days)
- 28-day mortality rate(28 days)
- 7-day mortality rate(7 days)