Status:

RECRUITING

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Lead Sponsor:

First Affiliated Hospital of Wannan Medical College

Collaborating Sponsors:

Suzhou Municipal Hospital of Anhui Province

the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China

Conditions:

Septic Cardiomyopathy

Septic Shock

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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 ef...

Eligibility Criteria

Inclusion

  • 1\. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
  • 2\. Age ≥ 18 years.

Exclusion

  • 1\. Pregnant or breastfeeding women;
  • 2\. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components;
  • 3\. Severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, HIV, etc.;
  • 4\. Severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (New York Heart Association \[NYHA\] Class IV);
  • 5\. Any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma;
  • 6\. Use of Ginseng and Aconite Injection for less than 48 hours;
  • 7\. Patients expected to die within 48 hours;
  • 8\. Patients deemed unsuitable for this study by the investigator.

Key Trial Info

Start Date :

October 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

440 Patients enrolled

Trial Details

Trial ID

NCT06898723

Start Date

October 1 2024

End Date

September 30 2026

Last Update

March 27 2025

Active Locations (1)

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

Wuhu, Anhui, China, 241001