Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status and phase: Begins enrollment in 4 months; Phase 2

Conditions: Sepsis-Induced Myocardial Dysfunction

Treatments: Drug: Danhong injection; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07375862

KY-2025-313

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Patients with a diagnosis of sepsis-induced myocardial dysfunction (SIMD).

Exclusion criteria

1. Patients with significant primary cardiac diseases, including unstable coronary artery disease, severe cardiomyopathy, or severe valvular heart disease.
2. Exclusion criteria included long-term use of Danhong Injection or recent use of other medication with potential significant impact on cardiac function.
3. Patients with severe hepatic dysfunction (defined as Child-Pugh class C) or severe renal insufficiency (defined as creatinine clearance <30 mL/min) were excluded.
4. Patients with a known allergy to any component of Danhong Injection or a history of severe allergic diathesis were excluded.
5. Pregnant or lactating women
6. Patients with severe mental illness or inability to cooperate with the study.
7. Participation in other drug clinical trials within 3 months prior to enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups, including a placebo group

Danhong Injection

Experimental group

Treatment:

Drug: Danhong injection

Control group

Placebo Comparator group

Treatment:

Drug: Saline