Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06898723

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Led by First Affiliated Hospital of Wannan Medical College · Updated on 2025-03-27

440

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Wannan Medical College

Lead Sponsor

S

Suzhou Municipal Hospital of Anhui Province

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study focuses on improving heart function in patients with life-threatening blood infections (septic shock). When the body fights severe infections, the heart sometimes struggles to pump blood effectively, which can lead to dangerous complications. Current treatments like intravenous fluids and blood pressure medications have limitations in protecting heart function. This multicenter clinical trial aims to evaluate whether adding Shenfu Injection - a traditional Chinese medicine preparation widely used to enhance cardiac function in cardiovascular diseases - to standard therapies can: 1. Prevent myocardial dysfunction during septic shock 2. Accelerate cardiac recovery if complications occur 3. Improve overall survival and clinical outcomes The randomized controlled design will compare therapeutic effects between two groups: one receiving standard septic shock treatment alone, and the other receiving standard treatment combined with Shenfu Injection.

CONDITIONS

Official Title

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients clinically diagnosed with septic shock meeting Sepsis 3.0 diagnostic criteria
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • History of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components
  • Severe underlying diseases affecting prognosis, including uncontrolled metastatic tumors, blood disorders, cachexia, active bleeding, severe malnutrition, or HIV
  • Severe cardiac conditions within the last three months such as acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, valvular heart disease, or congestive heart failure (NYHA Class IV)
  • Cardiac surgery or related procedures within the last three months
  • Use of Ginseng and Aconite Injection for less than 48 hours
  • Patients expected to die within 48 hours
  • Patients deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, China, 241001

Actively Recruiting

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Research Team

Q

Qiancheng Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis | DecenTrialz