Cardiovascular Phenotypes in Sepsis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Adults with suspected sepsis and hemodynamic instability requiring vasopressor support.

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 year after admission to the Intermediate Care Unit (IMCU), Intensive Care Unit (ICU) or Cardiac Care Unit (CCU).

Secondary outcomes

1

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.

Time frame
From admission to the IMCU, ICU, or CCU (baseline) until the date of in-hospital death or hospital discharge, whichever occurs first, assessed up to 90 days.
2

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.

Time frame
Baseline (within 72 hours of admission to the IMCU/ICU/CCU) to 3 months after baseline.
3

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.

Time frame
Up to 1 year after admission to the IMCU/ICU/CCU (baseline)
4

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.

Time frame
0-72 hours after admission to the IMCU/ICU/CCU

Other outcomes

1

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.

Time frame
From admission to the IMCU/ICU/CCU through 1 year after admission

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: