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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
440
The treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, China
RECRUITINGThe incidence of septic cardiomyopathy
Time frame: 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.
Time frame: 28 days
The incidence of septic cardiomyopathy
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
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