The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

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 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

• Septic Cardiomyopathy
• Septic Shock

Interventions

DRUG

Shenfu Injection

The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite

Sponsors & Collaborators

• Suzhou Municipal Hospital of Anhui Province

  collaborator OTHER

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

  collaborator UNKNOWN

• Wuhu County Traditional Chinese Medicine Hospital

  collaborator OTHER

• Wuhu first people's hospital

  collaborator UNKNOWN

• Wuhu City Second People's Hospital

  collaborator OTHER

• Xuancheng people's hospital

  collaborator UNKNOWN

• Tongling People's Hospital

  collaborator OTHER_GOV

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• The Fourth Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The Third People's Hospital of Bengbu

  collaborator OTHER_GOV

• Fuyang people's hospital

  collaborator OTHER

• Chaohu Hospital of Anhui Medical University

  collaborator OTHER

• The First People's Hospital of Bengb

  collaborator UNKNOWN

• Guangde people's hospital

  collaborator UNKNOWN

• Fuyang Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Taihe County Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Wannan Medical College

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• China

Study Locations