Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating … (NCT07375862) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction
140 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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.
What they're measuring
1
Left Ventricular Ejection Fraction
Timeframe: 24 hours before treatment, 3 days after treatment
Trial details
NCT IDNCT07375862
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine