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NCT Number: NCT07375862

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

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.

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Key information

Conditions

Sepsis-Induced Myocardial Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
Participation in other drug clinical trials within 3 months prior to enrollment.

Treatment and study plan

Danhong injection

Drug

Danhong 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

Drug

Intravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days.

Primary outcomes

Left Ventricular Ejection Fraction

Time frame: 24 hours before treatment, 3 days after treatment

Secondary outcomes

cardiac troponin T

Time frame: Before treatment, 3 days after treatment, 7 days after treatment
28-day mortality

Time frame: 28 days after enrollment

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jan 29, 2026
Registry last updated: Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.