Investigating the Clinical Benefits and Underlying Mechanisms of Danhong Injection in Modulating Mitochondrial Homeostasis Against Sepsis-Associated Myocardial Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Danhong injection, Saline.
- Who it may be relevant to
- Registry conditions: Sepsis-Induced Myocardial Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Danhong injection
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. - Drug Saline
Intravenous drip of 100 ml 0.9% saline solution, twice daily, for 7 consecutive days.
Primary outcome measures
- Left Ventricular Ejection Fraction [Time frame: 24 hours before treatment, 3 days after treatment]
Secondary outcome measures (2)
- cardiac troponin T [Time frame: Before treatment, 3 days after treatment, 7 days after treatment]
- 28-day mortality [Time frame: 28 days after enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07375862 · KY-2025-313