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Protective effect of Early shenfu injection on septic cardiomyopathy in elderly patients with SEPSIS in ICU: a randomized, controlled, multicenter clinical trial

Protective effect of Early shenfu injection on septic cardiomyopathy in elderly patients with SEPSIS in ICU: a randomized, controlled, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088766
Enrollment
Unknown
Registered
2024-08-26
Start date
2023-08-03
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis cardiomyopathy

Interventions

experimental group:shenfu injection was given 200ml/d for 7 days
control group:conventional treatment according to guidelines for sepsis and septic shock

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age: ?60 years old; (2) Sepsis was diagnosed (according to sepsis 3.0 diagnostic criteria: infection caused host response disorder, resulting in life-threatening organ function damage); (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); (4) Informed consent signed by the patient or his/her agent.

Exclusion criteria

Exclusion criteria: (1) Patients with allergic history or contraindications to Shenfu injection (such as recent history of cerebral hemorrhage); (2) pregnant women; (3) Patients unable to complete bedside cardiac ultrasound examination for various reasons; (4) Patients after cardiac surgery; (5) The patient concurrently participates in another clinical study; (6) Patients with serious underlying heart disease, such as dilated heart disease, valvular disease, ventricular septal defect, congenital heart disease, etc. (7) Patients who can expect to die within 48 hours; (8) Patients considered unsuitable for the study by the researcher for various reasons.

Design outcomes

Primary

MeasureTime frame
Incidence of sepsis cardiomyopathy;

Secondary

MeasureTime frame
When sepsis cardiomyopathy occurs;7 days heart function recovery rate;14 days heart function recovery rate;28-day mortality rate;

Countries

China

Contacts

Public ContactJing Wang

Zhongnan Hospital of Wuhan University

wangjing9279@163.com+86 131 0062 2008

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026