The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

NCT06898723 | Recruiting Phase 4

• 1 other identifier: 2024109
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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 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. 1.Prevent myocardial dysfunction during septic shock
2. 2.Accelerate cardiac recovery if complications occur
3. 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

Keywords

Septic Shock; Cardiac Dysfunction; Shenfu Injection; Myocardial Protection; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• The incidence of septic cardiomyopathy

  Day 3

• Improvement in Sequential Organ Failure Assessment (SOFA) score

  Day 3

• Improvement in Sequential Organ Failure Assessment (SOFA) Score

  Day 7

• Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)

  3 days

• Fluid Balance (Total Fluid Intake and Output Measurement in Milliliters)

  7 days

Study Arms (2)

Shenfu Injection Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Treatment will be conducted in accordance with international and Chinese guidelines for sepsis.

Interventions

Shenfu Injection DRUG

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

Shenfu Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Pregnant or breastfeeding women;
• \. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components;
• \. 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.;
• \. 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);
• \. 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;
• \. Use of Ginseng and Aconite Injection for less than 48 hours;
• \. Patients expected to die within 48 hours;
• \. Patients deemed unsuitable for this study by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhu, Anhui, 241001, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Shen-Fu

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qiancheng Xu

CONTACT

86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this clinical trial, in addition to the ultrasound assessors mentioned above, other members of the research team, including data analysts and study coordinators, will also be masked. These individuals will not have access to specific group assignment information during the trial to ensure the objectivity of data analysis and the reliability of the results. Furthermore, participants and their immediate family members will be informed about the basic aspects of the trial but will not be disclosed the specific treatment group assignments to minimize potential bias and influence. All randomization information will be managed by an independent randomization center to ensure the integrity of the masking process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 27, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)