Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- Left Ventricular Ejection Fraction
研究概览
简要总结
This study aims to evaluate the clinical efficacy of Danhong injection in patients with septic myocardial injury through a prospective randomized controlled trial. The study will enroll 140 patients meeting criteria for septic myocardial injury, divided into a Danhong injection group and a placebo group. Primary endpoints include changes in myocardial injury markers and improvement rates in cardiac function over 7 days, while secondary endpoints include 28-day mortality rates. This will determine whether Danhong injection possesses myocardial protective effects and provide evidence-based support for expanding its clinical indications.
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
- None
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 who met the Sepsis-3 criteria, defined by a suspected or confirmed infection and an increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more from baseline.
- •Patients with a diagnosis of sepsis-induced myocardial dysfunction (SIMD).
排除标准
- •Patients with significant primary cardiac diseases, including unstable coronary artery disease, severe cardiomyopathy, or severe valvular heart disease.
- •Exclusion criteria included long-term use of Danhong Injection or recent use of other medication with potential significant impact on cardiac function.
- •Patients with severe hepatic dysfunction (defined as Child-Pugh class C) or severe renal insufficiency (defined as creatinine clearance <30 mL/min) were excluded.
- •Patients with a known allergy to any component of Danhong Injection or a history of severe allergic diathesis were excluded.
- •Pregnant or lactating women
- •Patients with severe mental illness or inability to cooperate with the study.
- •Participation in other drug clinical trials within 3 months prior to enrollment.
研究组 & 干预措施
Danhong Injection
干预措施: Danhong injection (Drug)
Control group
干预措施: Saline (Drug)
结局指标
主要结局
Left Ventricular Ejection Fraction
时间窗: 24 hours before treatment, 3 days after treatment
次要结局
- cardiac troponin T(Before treatment, 3 days after treatment, 7 days after treatment)
- 28-day mortality(28 days after enrollment)