An observational study in Sepsis, sponsored by Qin Zhang. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Qin Zhang · Observational
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.
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. 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 meeting the Sepsis-3 criteria who concurrently developed new-onset myocardial injury (troponin elevation exceeding the upper limit of normal, e.g., > 0.05 ng/mL) and/or echocardiographic evidence of myocardial dysfunction (ejection fraction \< 50%) or B-type natriuretic peptide (BNP) > 500 pg/mL directly attributable to sepsis. 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.
During the study periods, a total of 652 ICU patients were initially assessed for eligibility. Based on our predefined criteria, 85 patients were excluded: meeting absolute exclusion criteria (n = 18), failing to meet specific strict group definitions (n = 14), declining to participate or missing informed consent (n = 19), lacking baseline plasma samples within 24 hours (n = 16), and having incomplete echocardiographic or core clinical data (n = 18). Ultimately, 567 critically ill patients were enrolled, comprising 417 septic patients (including 104 who developed SIC) and 150 non-septic controls.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 567 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Qin Zhang is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critical ill patients without sepsis; Patients with sepsis and patients diagnosed with septic cardiomyopathy.
Categorized into one of the following three mutually exclusive cohorts within 24 hours of ICU admission:
Exclusion Criteria:
Critically ill patients diagnosed with sepsis. In this observational cohort, a subset of these patients received Ulinastatin based solely on the attending physicians' clinical experience and standard routine care, rather than a predefined study protocol. For those who received the treatment, the typical regimen was Ulinastatin (intravenous), 500,000 U, once daily (qd) during their ICU stay.
Drug: Ulinastatin
Critically ill patients without sepsis admitted to the ICU. These patients received standard intensive care appropriate for their primary diagnoses and did not receive Ulinastatin treatment.
Observational exposure. Ulinastatin was administered intravenously based solely on the attending physicians' clinical judgment during routine care, typically at a dosage of 500,000 U, once daily (qd). It was not assigned by a predefined study protocol.
Incidence of Sepsis-Induced Cardiomyopathy (SIC)
Number of participants who develop sepsis-induced cardiomyopathy during their ICU stay
Time frame: During ICU stay (assessed up to day 28)
Plasma Levels of KKS Pathway Proteins (KLK1/B1R/Bradykinin/iNOS)
Concentrations of KLK1, B1R, bradykinin, and iNOS measured in plasma to investigate the mechanistic pathway through which Ulinastatin suppresses sepsis-induced cardiomyopathy.
Time frame: Baseline (within 24 hours of admission)
28-Day All-Cause Mortality
Overall survival status evaluated at 28 days following ICU admission.
Time frame: 28 days
Echocardiographic Parameters of Cardiac Function
Quantitative assessment of Echocardiographic Parameters of Cardiac Function, such as Left Ventricular Ejection Fraction (LVEF) used for SIC diagnosis.
Time frame: Baseline (within 24 hours of admission)
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Qin Zhang