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

NCT07375862 | Not Yet Recruiting Phase 2

• 1 other identifier: KY-2025-313
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sepsis-Induced Myocardial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction

  24 hours before treatment, 3 days after treatment

Secondary Outcomes (2)

• cardiac troponin T

  Before treatment, 3 days after treatment, 7 days after treatment

• 28-day mortality

  28 days after enrollment

Study Arms (2)

Danhong Injection

EXPERIMENTAL

Drug: Danhong injection

Control group

PLACEBO COMPARATOR

Drug: Saline

Interventions

Saline DRUG

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

Control group

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.

Danhong Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients with significant primary cardiac diseases, including unstable coronary artery disease, severe cardiomyopathy, or severe valvular heart disease.
• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Interventions

danhong; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01