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NCT Number: NCT06898723

The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

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.

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Key information

Conditions

Septic Cardiomyopathy Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Wuhu, Anhui, 241001, China

Location status: Recruiting

Location contact

Shengsheng Tao

CONTACT

[email protected]

86-18315329399

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shenfu Injection

Drug

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

Primary outcomes

  1. The incidence of septic cardiomyopathy

    Time frame: Day 7

  2. Duration of vasopressor administration

    Time frame: 28 days

    The duration of vasopressor administration refers to the total time a patient requires vasopressor medications, measured in hours or days, to maintain blood pressure and support circulation.

Secondary outcomes

  1. The incidence of septic cardiomyopathy

    Time frame: Day 3

  2. Improvement in Sequential Organ Failure Assessment (SOFA) score

    Time frame: Day 3

    The SOFA score is used to assess and track the degree of organ dysfunction in critically ill patients. It evaluates six organ systems: respiratory, cardiovascular, hepatic, renal, coagulation, and neurological. Each organ system is scored from 0 to 4, with 0 indicating normal function and 4 indicating the most severe dysfunction. The total SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.

  3. Improvement in Sequential Organ Failure Assessment (SOFA) Score

    Time frame: Day 7

    The SOFA score is used to assess and track the degree of organ dysfunction in critically ill patients. It evaluates six organ systems: respiratory, cardiovascular, hepatic, renal, coagulation, and neurological. Each organ system is scored from 0 to 4, with 0 indicating normal function and 4 indicating the most severe dysfunction. The total SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.

  4. Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)

    Time frame: 3 days

    Fluid balance will be assessed by measuring total fluid intake and output in milliliters over a specified time frame. Intake includes oral and intravenous fluids, while output includes urine output, and drainage. The net fluid balance will be calculated as intake minus output, providing an indication of fluid status and potential fluid overload or deficit.

  5. Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)

    Time frame: 7 days

    Fluid balance will be assessed by measuring total fluid intake and output in milliliters over a specified time frame. Intake includes oral and intravenous fluids, while output includes urine output, and drainage. The net fluid balance will be calculated as intake minus output, providing an indication of fluid status and potential fluid overload or deficit.

  6. Duration of mechanical ventilation

    Time frame: 28 days

    The duration of mechanical ventilation is the total time a patient is on a ventilator, measured from initiation to extubation or removal. It reflects the severity of respiratory failure and recovery progress.

  7. Length of Intensive Care Unit(ICU) stay

    Time frame: 28 days

    The length of ICU stay refers to the total duration a patient spends in the Intensive Care Unit, measured in days. It indicates the severity of the patient's condition and recovery progress.

  8. Length of hospital stay

    Time frame: 28 days

    The length of hospital stay refers to the total duration a patient remains in the hospital, measured in days, from admission to discharge. It reflects the overall recovery time and treatment needs.

  9. 28-day mortality rate

    Time frame: 28 days

    The 28-day mortality rate refers to the percentage of patients who die within 28 days of admission, including those who are classified as deceased due to withdrawal of treatment or discharge against medical advice.

  10. 7-day mortality rate

    Time frame: 7 days

    The 7-day mortality rate refers to the percentage of patients who die within 7 days of admission, including those who are classified as deceased due to withdrawal of treatment or discharge against medical advice.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiancheng Xu

CONTACT

[email protected]

86-18297529106

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Collaborators

  • Chaohu Hospital of Anhui Medical University
  • Fuyang Traditional Chinese Medicine Hospital
  • Fuyang people's hospital
  • Guangde people's hospital
  • Suzhou Municipal Hospital of Anhui Province
  • Taihe County Traditional Chinese Medicine Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Bengbu Medical University
  • The Fourth Affiliated Hospital of Anhui Medical University
  • The Second Hospital of Anhui Medical University
  • The Third People's Hospital of Bengbu
  • Tongling People's Hospital
  • Wuhu City Second People's Hospital
  • Wuhu County Traditional Chinese Medicine Hospital
  • Wuhu first people's hospital
  • Xuancheng People's Hospital
  • the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China

Registry information

Official study title

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

Acronym: SHIELD Trail

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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