Clinical trial NCT06080282: Role of the Kallikrein-kinin System in Septic Cardiomyopathy
Official title: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Keywords: sepsis; Septic cardiomyopathy; KKS
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sepsis and patients diagnosed with septic cardiomyopathy.

Brief summary: The purpose of this study is to investigate whether there are differential expressions of molecules in the kallikrein-kinin system (KKS) pathway in septic cardiomyopathy, and to analyze their regulatory mechanisms and gene expression changes.

Detailed description: This study is designed as a prospective, single-center, prospective case-control study. The research plan mainly aims to collect clinical data and blood samples from patients with septic cardiomyopathy and the control group within the next 3 years (October 2023 to October 2025). Diagnostic criteria are as follows: (1) Diagnosis of sepsis is based on the SEPSIS 3.0 criteria, which is defined as a rapid increase in SOFA score by ≥2 points after infection as a clinical criterion for sepsis-related organ dysfunction. (2) Diagnostic criteria for septic cardiomyopathy include: diagnosis of sepsis and elevation of cardiac markers \[cardiac troponin I (cTnI) or BNP\]; systolic dysfunction: echocardiography shows LVEF \< 50%; diastolic dysfunction: Doppler ultrasound shows an E/A ratio (rapid filling phase/atrial contraction phase) ≤1 at the mitral valve; BNP \> 200 pg/mL; left ventricular fractional shortening (FS) \> 25%; normal or increased wall thickness, decreased left ventricular filling rate.

Eligibility criteria: Inclusion Criteria:

(1) Age range greater than 18 years. (2) Patients diagnosed with septic cardiomyopathy. (3) Clear determination of the cause of myocardial injury, such as the source of infection, bacterial culture results, etc. (4) Patients who are capable of cooperating and completing the necessary examinations and treatments.

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Exclusion Criteria:

(1) Presence of other significant underlying cardiovascular diseases, such as coronary heart disease, heart failure, etc. (2) Presence of other organ dysfunction that poses a significant threat to life, such as respiratory failure, liver failure, etc. (3) Presence of severe infections or inflammatory diseases unrelated to myocardial injury, such as severe acute pancreatitis. (4) History of receiving interventional treatments, such as immunomodulatory agents, anti-inflammatory drugs, etc. (5) Pregnant or lactating women. (6) Pediatric patients who are under the age of majority.

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Primary outcomes:
measure: Survival
timeFrame: 28 days
Secondary outcomes:
measure: Cardiac function
timeFrame: 24 hour
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: QIN Zhang, phd
role: PRINCIPAL_INVESTIGATOR
References: