About this trial
This prospective observational study will investigate cardiovascular phenotypes in adults with sepsis and hemodynamic instability. Approximately 400 patients requiring vasopressor support will be enrolled across multiple hospital sites. Within 72 hours of admission, participants will undergo peripheral vascular assessments, echocardiography, and blood sampling for cardiac, endothelial, and inflammatory biomarkers. Patients will be classified according to the presence or absence of peripheral vascular dysfunction and cardiac dysfunction. The primary aim is to examine the association between these cardiovascular phenotypes and one-year mortality. Secondary aims include evaluating biomarker profiles, characterizing myocardial injury, and assessing cardiac function at a 3-month follow-up. The study seeks to improve understanding of sepsis-related cardiovascular dysfunction and support development of more individualized management strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Suspected sepsis based on clinical evaluation and supporting laboratory findings
Hemodynamic instability, defined as mean arterial pressure < 65 mmHg despite adequate fluid resuscitation
Requirement for vasopressor support
Disqualifiers
Lack of informed consent
Advanced peripheral arterial disease, including: subclavian artery occlusion with vertebrobasilar symptoms, critical hand ischemia with tissue loss or non-healing wounds, multilevel occlusive disease affecting upper-extremity arteries, upper limb surgery or significant upper limb trauma within 30 days prior to admission, technical limitations preventing proper placement of the EndoPAT device (e.g., finger amputation, severe rheumatologic deformity, or marked extremity edema).
Trial population
Adult patients with suspected sepsis and hemodynamic instability requiring vasopressor support, recruited across multiple hospital critical care units including the Intermediate Care Unit (IMCU), Intensive Care Unit (ICU), Cardiac Care Unit (CCU) and Acute Care Unit (ACU).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Association between cardiovascular phenotypes and one-year mortality in sepsis
To assess the association between distinct cardiovascular phenotypes and one-year mortality in patients with sepsis. Cardiovascular phenotypes will be categorized as: (a) peripheral circulatory dysfunction (present vs. absent), (b) heart failure (present vs. absent), and (c) the combined presence of peripheral circulatory dysfunction and heart failure. One-year mortality will be analyzed according to phenotype group.
Secondary outcomes
Association between cardiovascular phenotypes and in-hospital mortality in sepsis
To assess the association between distinct cardiovascular phenotypes and in-hospital mortality in patients with sepsis. Cardiovascular phenotypes will be categorized as: (a) peripheral circulatory dysfunction (present vs. absent), (b) heart failure (present vs. absent), and (c) the combined presence of peripheral circulatory dysfunction and heart failure. In-hospital mortality will be analyzed according to phenotype group.
Change in echocardiographic indices of acute ventricular function and ventriculo-arterial coupling from baseline to 3 months
Transthoracic echocardiographic assessment of acute ventricular function and ventriculo-arterial coupling performed during the index hospitalization and at 3 months after baseline. Measurements may include conventional and advanced indices of left ventricular function, right ventricular function, and biventricular ventriculo-arterial coupling derived from standard echocardiographic views and Doppler measurements. Individual echocardiographic parameters will be reported separately as continuous or dichotomous variables, as appropriate. Changes in individual echocardiographic parameters from baseline to 3-month follow-up will be analyzed.
Association of integrated cardiovascular biomarkers with one-year and in-hospital mortality in sepsis
Cardiovascular phenotypes will be refined by integrating established cardiac biomarkers, including high-sensitivity cardiac troponin T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), together with serum markers of endothelial dysfunction and pro-coagulant activity. The association between biomarker-refined cardiovascular phenotypes and mortality will be evaluated to assess their prognostic value.
Association between emerging cardiovascular biomarkers and myocardial injury severity in sepsis
Emerging cardiovascular biomarkers will be measured in patients with sepsis using one blood sample obtained within 0-72 hours of admission to the IMCU/ICU/CCU. Biomarker levels will be analyzed in relation to the severity and progression of myocardial injury, as assessed by the established myocardial injury marker high-sensitivity cardiac troponin T (hs-cTnT) and relevant clinical parameters assessed within 0-72 hours of admission to the IMCU/ICU/CCU.
Other outcomes
Cardiovascular events during one-year follow-up after critical care admission
Cardiovascular events, including myocardial infarction, hospitalization for heart failure, and newly diagnosed clinically significant arrhythmias, will be recorded from admission to the IMCU/ICU/CCU through 1 year of follow-up.
Locations
Sponsors and contacts
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