left ventricular systolic dysfunction in patients with sepsis
Conditions
Interventions
Control group:Myocardial Peptide Mimetic plus Standard Therapy
Treatment group:Myocardial Peptide plus Standard Therapy
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years old (inclusive), any gender; 2. Assess and record whether the patient meets the diagnostic criteria for sepsis-induced left ventricular systolic dysfunction within 72 hours of ICU admission: (1) Meets the diagnostic criteria for sepsis; (2) Clinical manifestations: acute onset, acute cardiac dysfunction not related to ischemia, presenting in various forms: arrhythmias, systolic or diastolic dysfunction of the left and/or right ventricle, with or without reduced cardiac output. (3) Echocardiography meets any of the following (all must be measured and recorded): 1) Left ventricular systolic dysfunction (LVSD) (meeting any of the following): Left ventricular ejection fraction (LVEF) < 45%, aortic velocity-time integral (VTI) < 14 cm (4) Exclusion: 1) Acute heart failure caused by other reasons, including acute coronary syndrome (diagnostic criteria see Appendix 1), stress cardiomyopathy (diagnostic criteria see Appendix 2); 3. Obtain informed consent and signature from the patient or their legal representative; 4. Enroll within 24 hours after screening.
Exclusion criteria
Exclusion criteria: 1. Known poor prognosis conditions, such as severe traumatic brain injury, post-cardiac arrest, advanced malignant tumors, or end-stage severe systemic diseases. 2. Patients for whom withdrawal of advanced life support or treatment has been decided. 3. Declared brain death. 4. Severe valvular disease known to affect ventricular filling or outflow. 5. Acute cardiac dysfunction due to other causes, including fulminant myocarditis, acute coronary syndrome, or stress cardiomyopathy. 6. Chronic heart failure patients with New York Heart Association (NYHA) functional class II-IV [JACC Heart Fail. 2024 Aug;12(8):1487-1493]. 7. History of drug or food allergy, or known allergy to the study drug components. 8. Pregnant women, women planning pregnancy, or breastfeeding women. 9. Patients with an expected survival time less than 48 hours. 10. Patients considered by investigators to meet any other criteria unsuitable for enrollment. 11. Patients receiving extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) support at the time of enrollment. 12. Patients admitted to ICU for postoperative monitoring following cardiac surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean cardiovascular SOFA score over 7 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vasopressor-free days;7-day vasopressor inotrope Score (VIS);7-day change in cardiac function parameters;Duration of mechanical ventilation;In-hospital mortality;28-day all cause mortality;Change in cardiovascular SOFA score over 7 Days; | — |
Countries
China
Contacts
Public ContactDechang Chen
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed