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| Name | Class |
|---|---|
| Suzhou Municipal Hospital of Anhui Province | OTHER |
| the Second of Affiliated Hospital of Wannan Medical College, Wuhu, China | UNKNOWN |
| Wuhu County Traditional Chinese Medicine Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control Group | No Intervention | Treatment will be conducted in accordance with international and Chinese guidelines for sepsis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenfu Injection | Drug | The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiancheng Xu | Contact | 86-18297529106 | qianchengxu@wnmc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) | Recruiting | Wuhu | Anhui | 241001 | China |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| C492793 | Shen-Fu |
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| Wuhu first people's hospital | UNKNOWN |
| Wuhu City Second People's Hospital | OTHER |
| Xuancheng People's Hospital | OTHER |
| Tongling People's Hospital | OTHER_GOV |
| The Second Hospital of Anhui Medical University | OTHER |
| The Fourth Affiliated Hospital of Anhui Medical University | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| The Third People's Hospital of Bengbu | OTHER_GOV |
| Fuyang people's hospital | OTHER |
| Chaohu Hospital of Anhui Medical University | OTHER |
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
| Guangde people's hospital | UNKNOWN |
| Fuyang Traditional Chinese Medicine Hospital | UNKNOWN |
| Taihe County Traditional Chinese Medicine Hospital | UNKNOWN |
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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.
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |