Septic Cardiomyopathy, Septic Shock
Conditions
Keywords
Septic Shock, Cardiac Dysfunction, Shenfu Injection, Myocardial Protection, Randomized Controlled Trial
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. 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
DRUGShenfu Injection
The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite
Sponsors
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 People's Hospital of Bengb
Guangde people's hospital
Fuyang Traditional Chinese Medicine Hospital
Taihe County Traditional Chinese Medicine Hospital
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| The incidence of septic cardiomyopathy | Day 3 | — |
Countries
China
Contacts
Primary ContactQiancheng Xu
Outcome results
None listed