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.
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).
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.
Parallel
Danhong injection
DrugDanhong Injection for intravenous drip, dosage: 20 ml, diluted in 80 ml of 0.9% saline solution for intravenous drip, twice daily, for a continuous treatment period of 7 days.
Saline
DrugIntravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days.
Left Ventricular Ejection Fraction
cardiac troponin T
28-day mortality
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