Role of the Kallikrein-kinin System in Septic Cardiomyopathy

Sponsor

Qin Zhang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06080282

Collaborator

(none)

640

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

640 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Oct 14, 2024

Anticipated Study Completion Date :

Oct 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sepsis No intervention

Outcome Measures

Primary Outcome Measures

Survival [28 days]
Survival

Secondary Outcome Measures

Cardiac function [24 hour]
Echocardiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Qin Zhang

Investigators

Principal Investigator: QIN Zhang, phd, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qin Zhang, phd, Tongji Hospital

ClinicalTrials.gov Identifier:

NCT06080282

Other Study ID Numbers:

TJ-IRB202308109

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Qin Zhang, phd, Tongji Hospital

sepsis; Septic cardiomyopathy; KKS

Additional relevant MeSH terms:

Sepsis

Cardiomyopathies

Study Results

No Results Posted as of Oct 12, 2023