Role of the Kallikrein-kinin System in Septic Cardiomyopathy

Sepsis Clinical Trial

Official title:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080282
• Other study ID #: TJ-IRB202308109
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: October 14, 2025

Study information

• Verified date: January 2024
• Source: Tongji Hospital
• Contact: QIN Zhang, phd
• Phone: 15717154768
• Email: qzhang8[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: October 14, 2025
• Est. primary completion date: October 14, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Cardiomyopathies
• Sepsis

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Qin Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival	28 days
Secondary	Cardiac function	Echocardiography	24 hour