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Recruiting NCT06898723

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

Phase IV Interventional Septic Cardiomyopathy Septic Shock

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: Shenfu Injection.
Who it may be relevant to
Registry conditions: Septic Cardiomyopathy, Septic Shock. 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
China
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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Official title

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study

Overview

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.

Interventions

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

Primary outcome measures

  • The incidence of septic cardiomyopathy [Time frame: Day 7]
  • Duration of vasopressor administration [Time frame: 28 days]
Secondary outcome measures (10)
  • The incidence of septic cardiomyopathy [Time frame: Day 3]
  • Improvement in Sequential Organ Failure Assessment (SOFA) score [Time frame: Day 3]
  • Improvement in Sequential Organ Failure Assessment (SOFA) Score [Time frame: Day 7]
  • Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters) [Time frame: 3 days]
  • Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters) [Time frame: 7 days]
  • Duration of mechanical ventilation [Time frame: 28 days]
  • Length of Intensive Care Unit(ICU) stay [Time frame: 28 days]
  • Length of hospital stay [Time frame: 28 days]
  • 28-day mortality rate [Time frame: 28 days]
  • 7-day mortality rate [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

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
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medic — Wuhu

Identifiers

NCT: NCT06898723 · 2024109

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗