The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
2. Age ≥ 18 years.
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Shenfu Injection
DrugThe treatment will utilize Ginseng and Aconite Injection, which primarily consists of Red Ginseng and Aconite
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Shenfu Injection GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The incidence of septic cardiomyopathy
Time frame
Day 72
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 daysSecondary outcomes
1
The incidence of septic cardiomyopathy
Time frame
Day 32
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 33
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 74
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Wannan Medical College
Lead sponsor
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
Source ClinicalTrials.gov