The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

NCT06898723 — Phase 4, Recruiting, 440 participants, First Affiliated Hospital of Wannan Medical College

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06898723, acronym SHIELD Trail
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment440 (Estimated)
SponsorFirst Affiliated Hospital of Wannan Medical College (Other); collaborators: Suzhou Municipal Hospital of Anhui Province, the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China, Wuhu County Traditional Chinese Medicine Hospital, Wuhu first people's hospital, Wuhu City Second People's Hospital, Xuancheng People's Hospital, Tongling People's Hospital, The Second Hospital of Anhui Medical University, The Fourth Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui Medical University, The Third People's Hospital of Bengbu, Fuyang people's hospital, Chaohu Hospital of Anhui Medical University, The First Affiliated Hospital of Bengbu Medical University, Guangde people's hospital, Fuyang Traditional Chinese Medicine Hospital, Taihe County Traditional Chinese Medicine Hospital
ConditionsSeptic Cardiomyopathy, Septic Shock
InterventionsShenfu Injection (Drug)
Datesstart 2024-10-01, primary completion 2026-09-30 (estimated), completion 2026-09-30 (estimated), first posted 2025-03-27, last updated 2025-03-27
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Septic Cardiomyopathy All trials for Septic Shock All trials of Shenfu Injection

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Shenfu Injection GroupExperimentalDrug: Shenfu InjectionTreatment 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
Control GroupNo interventionTreatment will be conducted in accordance with international and Chinese guidelines for sepsis.
  • Shenfu Injection (Drug): The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite

+Outcome measures

Primary outcomes

  • The incidence of septic cardiomyopathy [Day 7]
  • Duration of vasopressor administration [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

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)Wuhu, AnhuiChinaRecruiting