NCT06080282

Role of the Kallikrein-kinin System in Septic Cardiomyopathy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 567 (actual)
• Sponsor: Qin Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 prospective observational study enrolled 567 critically ill adults within 24 hours of their intensive care unit (ICU) admission across three medical centers in Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology (Wuhan, China)Wuhan, China. Recruitment occurred during two distinct periods: June 2017 to September 2018 and September 2023 to October 2024. Patients were categorized according to Sepsis-3.0 criteria into non-sepsis and sepsis groups(45). The non-sepsis control group comprised individuals without evidence of infection whose Sequential Organ Failure Assessment (SOFA) scores remained below 2 points. Exclusion criteria included: 1) paraquat poisoning; 2) age under 18 years at diagnosis; 3) acute cardiovascular and cerebrovascular diseases unrelated to inflammation; 4) history of cardiac surgery; 5) pregnancy or breastfeeding; and 6) intellectual or psychological disorders precluding suitable study participation. Within the sepsis cohort, patients were further stratified based on the manifestation of SIC, defined as meeting at least one diagnostic criterion within the initial 24 hours of ICU admission: echocardiographic evidence of left ventricular dysfunction (ejection fraction below 50%), troponin T elevation exceeding 0.05 ng/mL, or B-type natriuretic peptide (BNP) levels greater than 500 pg/mL(46). All echocardiographic assessments were performed by accredited sonographers from the Tongji Clinic Echo Lab, with subsequent interpretations conducted by board-certified cardiologists from the same institution. Detailed demographic and clinical characteristics of this cohort have been previously documented(47).

Conditions

• Sepsis

Timeline

• Start date: 2017-06-01
• Primary completion: 2024-10-14
• Completion: 2024-10-14
• First posted: 2023-10-12
• Last updated: 2026-03-30

Locations

1 site across 1 country: China