The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis (SHIELD Trail)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Septic Cardiomyopathy
• Intervention / Treatment: Drug: Shenfu Injection

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qiancheng Xu; Phone Number: 86-18297529106; Email: qianchengxu@wnmc.edu.cn

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China, 241001
      • Recruiting
      • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
      • Contact: Shengsheng Tao; Phone Number: 86-18315329399; Email: taoshengsheng@yjsyy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shenfu Injection Group; Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. On this basis, Shenfu Injection will be administered at a dosage of 50-100 ml (according to the medication practices of each participating center), diluted with an equal volume of 5% glucose and infused intravenously twice a day	Drug: Shenfu Injection; The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite
No Intervention: Control Group; Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of septic cardiomyopathy		Day 7
Duration of vasopressor administration	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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of septic cardiomyopathy		Day 3
Improvement in Sequential Organ Failure Assessment (SOFA) score	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.	Day 3
Improvement in Sequential Organ Failure Assessment (SOFA) Score	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.	Day 7
Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)	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.	3 days
Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)	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.	7 days
Duration of mechanical ventilation	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.	28 days
Length of Intensive Care Unit(ICU) stay	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.	28 days
Length of hospital stay	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.	28 days
28-day mortality rate	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.	28 days
7-day mortality rate	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.	7 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Septic Shock; Cardiac Dysfunction; Myocardial Protection; Shenfu Injection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Cardiomyopathies; Shock, Septic
• Other Study ID Numbers: 2024109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No