Septic CardiomyopathyNCT06793020
Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model
An observational study of Septic Cardiomyopathy, run by Vilnius University at 2 sites in 2 countries.
Trial summary
The goal of this observational study is to evaluate whether a new integrated mathematical model can improve the accuracy of diagnosing septic cardiomyopathy and predicting clinical outcomes in adult patients with suspected septic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Cardiomyopathy
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 Mar 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for sepsis or septic shock in the Intensive Care Units of two university hospitals.
Who may be able to join
- Age 18 years or older;
- Sepsis according to SEPSIS-3 criteria:
- Suspected/confirmed infection and
- SOFA (Sequential Organ Failure Assessment) score ≥ 2 or qSOFA score ≥ 2;
- Septic shock according to SEPSIS-3 criteria:
- Sepsis is diagnosed and
Show all 10Show fewer
- Vasopressor infusion is used to maintain a mean arterial pressure (MAP) ≥ 65 mmHg and
- Lactate \> 2 mmol/l;
- Cardiovascular support requirement for norepinephrine \> 0.1 mcg/kg/min infusion;
- Signed informed consent form (ICF);
Who cannot join
- Individuals under 18 years of age;
- Has uncompensated cardiovascular disease:
- Cardiogenic shock;
- Congenital heart disease;
- Heart failure NYHA functional class IV;
- Refusal to participate in the study.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Tomas Jovaisa, Prof, +37062697567, tomas.jovaisa@santa.lt
Tomas Jovaisa, Prof
Poland1 site, 1 recruiting
- Recruiting
University Clinical Centre of the Medical University of Warsaw
Warsaw
Mateusz Zawadka, Dr, +48505018394, mateusz.zawadka@wum.edu.pl
Mateusz Zawadka, Dr
About this study
Official title: Use of an Integrated Mathematical Model for the Diagnosis, Treatment and Outcome Assessment of Septic Cardiomyopathy
The goal of this observational study is to evaluate whether a new integrated mathematical model can improve the accuracy of diagnosing septic cardiomyopathy and predicting clinical outcomes in adult patients with suspected septic cardiomyopathy. The study aims to determine whether the integrated mathematical model enhances diagnostic accuracy and improves the prediction of clinical outcomes in these patients.
Read the detailed description
This multicenter, prospective observational study will enrol adult patients treated for sepsis or septic shock in the intensive care unit (ICU). Eligible patients will be identified based on predefined inclusion and exclusion criteria and enrolled in the study after obtaining informed consent. The primary transthoracic echocardiography will be performed within 48 hours of enrollment to gather detailed echocardiographic data, while key hemodynamic measurements will be recorded simultaneously.
A second transthoracic echocardiography will be conducted within 10 days of the initial evaluation. This follow-up assessment will occur during continued ICU care after discontinuation of vasopressor therapy or during hospitalization in the general ward, depending on the patient's clinical progression. The echocardiographic and hemodynamic parameters from both the initial and follow-up evaluations will be input into a mathematical formula designed to integrate these data into a single cardiovascular estimate. This integrated model will then be used to assess its ability to predict patient outcomes.
Following hospital discharge, patients will be followed for up to one year. During this period, a long-term follow-up assessment will be conducted, during which patients will complete the SF-36 quality of life questionnaire. This follow-up will assess patients\' overall health, functional status, frequency of healthcare visits, and need for nursing care. These data will provide insights into the long-term impact of sepsis and septic cardiomyopathy on survivors beyond the acute phase of their illness.
This study will evaluate whether the use of an integrated model that combines clinical parameters with echocardiographic measurements can improve the accuracy of diagnosing septic cardiomyopathy and provide valuable predictions of clinical outcomes. Additionally, the study will assess the course of septic cardiomyopathy and its impact on one-year follow-up outcomes, including patient quality of life. A broadly applicable diagnostic approach could allow for timely treatment adjustments, reduce the burden of sepsis-related complications, and improve overall patient outcomes.
- Conditions
- Septic Cardiomyopathy
- Keywords
- Septic cardiomyopathy, Sepsis, Septic shock
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of septic cardiomyopathy when comparing a new clinical-echocardiographic model with the standard diagnostic method (left ventricular ejection fraction).
Incidence of septic cardiomyopathy, evaluated by comparing the diagnostic accuracy of a new clinical-echocardiographic model with the standard method, left ventricular ejection fraction (LVEF) measurement. The study will determine whether the new model improves the diagnosis of septic cardiomyopathy in patients with sepsis or septic shock.
Measured: From enrollment to the end of one-year follow-up.
Secondary outcomes (5)
Assessing the severity of septic cardiomyopathy and determining the severity grade.
This will be done by applying clinical and echocardiographic data to the integrated mathematical model, which will then categorize the severity of the condition into predefined severity grades. The assessment aims to provide a more nuanced understanding of the diseases impact on cardiac function and to validate the models ability to stratify patients based on the severity of their condition.
Measured: From enrollment to the end of one-year follow-up.
Length of intensive care unit and hospital stay
Total cumulative number of days spent in intensive care unit and hospital
Measured: Intensive care unit days spent per patient: within 60 days following intensive care unit admission. Hospital days spent per patient: from admission up to 30 days.
Mortality
Mortality during intensive care unit stay, in hospital and at 1 year
Measured: Within 1 year of inclusion
Recovery of cardiac function
Changes in the integrated mathematical model during hospitalization
Measured: Within 30 days of inclusion
Long-term health and functional outcomes
Heath-related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Assessment of changes in functional capacity, number of visits to healthcare facilities, and the need for nursing care.
Measured: Within 1 year of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start17 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Responsible party
- Principal investigator, Tomas Jovaisa, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793020
- Sponsor's protocol ID
- 2024-3-1574-1032
- Other IDs
- 2024/3-1574-1032
- Status last verified
- Aug 2024
- First submitted
- 16 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Integrated Mathematical Model for the Diagnosis, Treatment and Outcome Assessment of Septic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06793020
- Acronym / sponsor ID
- 2024-3-1574-1032
- Conditions
- Septic Cardiomyopathy
- Keywords
- Septic cardiomyopathy, Sepsis, Septic shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Study start
- 17 Mar 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate whether a new integrated mathematical model can improve the accuracy of diagnosing septic cardiomyopathy and predicting clinical outcomes in adult patients with suspected septic cardiomyopathy. The study aims to determine whether the integrated mathematical model enhances diagnostic accuracy and improves the prediction of clinical outcomes in these patients.
Detailed description
This multicenter, prospective observational study will enrol adult patients treated for sepsis or septic shock in the intensive care unit (ICU). Eligible patients will be identified based on predefined inclusion and exclusion criteria and enrolled in the study after obtaining informed consent. The primary transthoracic echocardiography will be performed within 48 hours of enrollment to gather detailed echocardiographic data, while key hemodynamic measurements will be recorded simultaneously.
A second transthoracic echocardiography will be conducted within 10 days of the initial evaluation. This follow-up assessment will occur during continued ICU care after discontinuation of vasopressor therapy or during hospitalization in the general ward, depending on the patient's clinical progression. The echocardiographic and hemodynamic parameters from both the initial and follow-up evaluations will be input into a mathematical formula designed to integrate these data into a single cardiovascular estimate. This integrated model will then be used to assess its ability to predict patient outcomes.
Following hospital discharge, patients will be followed for up to one year. During this period, a long-term follow-up assessment will be conducted, during which patients will complete the SF-36 quality of life questionnaire. This follow-up will assess patients\' overall health, functional status, frequency of healthcare visits, and need for nursing care. These data will provide insights into the long-term impact of sepsis and septic cardiomyopathy on survivors beyond the acute phase of their illness.
This study will evaluate whether the use of an integrated model that combines clinical parameters with echocardiographic measurements can improve the accuracy of diagnosing septic cardiomyopathy and provide valuable predictions of clinical outcomes. Additionally, the study will assess the course of septic cardiomyopathy and its impact on one-year follow-up outcomes, including patient quality of life. A broadly applicable diagnostic approach could allow for timely treatment adjustments, reduce the burden of sepsis-related complications, and improve overall patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for sepsis or septic shock in the Intensive Care Units of two university hospitals.
Key inclusion criteria (10 listed)
- Age 18 years or older;
- Sepsis according to SEPSIS-3 criteria:
- Suspected/confirmed infection and
- SOFA (Sequential Organ Failure Assessment) score ≥ 2 or qSOFA score ≥ 2;
- Septic shock according to SEPSIS-3 criteria:
Key exclusion criteria (6 listed)
- Individuals under 18 years of age;
- Has uncompensated cardiovascular disease:
- Cardiogenic shock;
- Congenital heart disease;
- Heart failure NYHA functional class IV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of septic cardiomyopathy when comparing a new clinical-echocardiographic model with the standard diagnostic method (left ventricular ejection fraction).
Time frame: From enrollment to the end of one-year follow-up.
Incidence of septic cardiomyopathy, evaluated by comparing the diagnostic accuracy of a new clinical-echocardiographic model with the standard method, left ventricular ejection fraction (LVEF) measurement. The study will determine whether the new model improves the diagnosis of septic cardiomyopathy in patients with sepsis or septic shock.
5 secondary outcomes
Assessing the severity of septic cardiomyopathy and determining the severity grade.
Time frame: From enrollment to the end of one-year follow-up.
Length of intensive care unit and hospital stay
Time frame: Intensive care unit days spent per patient: within 60 days following intensive care unit admission. Hospital days spent per patient: from admission up to 30 days.
Mortality
Time frame: Within 1 year of inclusion
Recovery of cardiac function
Time frame: Within 30 days of inclusion
Long-term health and functional outcomes
Time frame: Within 1 year of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Clinical Centre of the Medical University of Warsaw
Warsaw, Poland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Cardiomyopathy, run by Vilnius University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lithuania, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of septic cardiomyopathy when comparing a new clinical-echocardiographic model with the standard diagnostic method (left ventricular ejection fraction). (time frame: From enrollment to the end of one-year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.