Protective effect of Early shenfu injection on septic cardiomyopathy in elderly patients with SEPSIS in ICU: a randomized, controlled, multicenter clinical trial
- Conditions
- Sepsis cardiomyopathy
- Registration Number
- ChiCTR2400088766
- Lead Sponsor
- Zhongnan Hospital of Wuhan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
(1) Age: ?60 years old;<br>(2) Sepsis was diagnosed (according to sepsis 3.0 diagnostic criteria: infection caused host response disorder, resulting in life-threatening organ function damage);<br>(3) There is no sepsis cardiomyopathy (diagnostic criteria for sepsis cardiomyopathy: there is no unified diagnostic criteria at present, which is defined as excluding acute coronary syndrome and stress cardiomyopathy based on previous studies. Cardiac ultrasound showed left ventricular systolic dysfunction, and EF<50% or cTnI higher than 2 times the normal value);<br>(4) Informed consent signed by the patient or his/her agent.
(1) Patients with allergic history or contraindications to Shenfu injection (such as recent history of cerebral hemorrhage);<br>(2) pregnant women;<br>(3) Patients unable to complete bedside cardiac ultrasound examination for various reasons;<br>(4) Patients after cardiac surgery;<br>(5) The patient concurrently participates in another clinical study;<br>(6) Patients with serious underlying heart disease, such as dilated heart disease, valvular disease, ventricular septal defect, congenital heart disease, etc.<br>(7) Patients who can expect to die within 48 hours;<br>(8) Patients considered unsuitable for the study by the researcher for various reasons.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of sepsis cardiomyopathy;
- Secondary Outcome Measures
Name Time Method When sepsis cardiomyopathy occurs;7 days heart function recovery rate;14 days heart function recovery rate;28-day mortality rate;