Cardiovascular Phenotypes in Sepsis (CaPS)

February 26, 2026 updated by: Jonas Persson, Karolinska Institutet
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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Sepsis is frequently accompanied by myocardial injury, myocardial dysfunction, and peripheral circulatory abnormalities, all of which contribute to hemodynamic instability and increased mortality. Despite their clinical importance, distinct cardiovascular phenotypes in sepsis have not been clearly defined, and no established guidelines exist for evaluating or managing sepsis-related myocardial dysfunction. This study aims to characterize cardiovascular phenotypes based on peripheral vascular function and cardiac performance, and to assess their association with clinical outcomes.

This is a prospective, multicenter observational cohort study enrolling 400 adults with suspected sepsis and hemodynamic instability requiring vasopressor support. Eligible patients will be included within 72 hours of admission to an Intermediate Care Unit, Intensive Care Unit, Cardiac Care Unit, or Acute Care Unit. After enrollment, participants will undergo standardized assessments of peripheral endothelial function using the EndoPAT device and capillary refill time measurement. A comprehensive echocardiographic evaluation will be performed to assess biventricular function and left-a dn right ventricular-arterial coupling. Blood samples will be collected and stored for analysis of cardiac biomarkers (including high-sensitivity cardiac troponin and NT-proBNP), as well as inflammatory, endothelial, glycocalyx, and thrombotic biomarkers.

Participants will be classified into cardiovascular phenotypes: ; i) peripheral vascular dysfunction, ii) cardiac dysfunction, iii) a combination of peripheral vascular dysfunction and cardiac dysfunction or iv) no dysfunction. The primary objective is to evaluate the association between these phenotypes and one-year all-cause mortality using survival analysis methods such ax Cox regression. Secondary objectives include examining biomarker patterns associated with cardiovascular dysfunction, assessing the severity and progression of myocardial injury, and evaluating changes in cardiac function at a three-month follow-up visit where repeat EndoPAT testing, capillary refill time assessment, echocardiography, and blood sampling will be performed.

Long-term clinical outcomes, including cardiovascular events and mortality, will be obtained through the electronic health register. The study aims to improve understanding of the interplay between microcirculatory dysfunction, myocardial injury, and cardiac performance in sepsis, and to support development of individualized risk stratification and future clinical management strategies.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

Inclusion Criteria:

  • 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
  • Inclusion within 72 hours of admission to an Intermediate Care Unit (IMCU), Intensive Care Unit (ICU), Cardiac Care Unit (CCU), or Acute Care Unit (ACU)

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adults with suspected sepsis and hemodynamic instability requiring vasopressor support.
Participants are enrolled prospectively across multiple hospital sites and undergo standardized assessments of peripheral vascular function, echocardiography, and biomarker sampling. No interventions are assigned as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between cardiovascular phenotypes and one-year mortality in sepsis
Time Frame: Up to 1 year after admission to the Intermediate Care Unit (IMCU), Intensive Care Unit (ICU) or Cardiac Care Unit (CCU).
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.
Up to 1 year after admission to the Intermediate Care Unit (IMCU), Intensive Care Unit (ICU) or Cardiac Care Unit (CCU).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between cardiovascular phenotypes and in-hospital mortality in sepsis
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.
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.
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.
Change in echocardiographic indices of acute ventricular function and ventriculo-arterial coupling from baseline to 3 months
Time Frame: Baseline (within 72 hours of admission to the IMCU/ICU/CCU) to 3 months after baseline.
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.
Baseline (within 72 hours of admission to the IMCU/ICU/CCU) to 3 months after baseline.
Association of integrated cardiovascular biomarkers with one-year and in-hospital mortality in sepsis
Time Frame: Up to 1 year after admission to the IMCU/ICU/CCU (baseline)
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.
Up to 1 year after admission to the IMCU/ICU/CCU (baseline)
Association between emerging cardiovascular biomarkers and myocardial injury severity in sepsis
Time Frame: 0-72 hours after admission to the IMCU/ICU/CCU
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.
0-72 hours after admission to the IMCU/ICU/CCU

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events during one-year follow-up after critical care admission
Time Frame: From admission to the IMCU/ICU/CCU through 1 year after 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.
From admission to the IMCU/ICU/CCU through 1 year after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 6, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaPS
  • Dnr 2025-04572-01 (Registry Identifier: Swedish Ethics Review Authority (Etikprövningsmyndigheten))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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