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NCT Number: NCT07529730

Outcomes of Surgical Treatment in Patients With Infective Endocarditis

Infective endocarditis (IE) is a severe disease associated with significant morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. In complicated cases, surgical intervention is frequently required.

This retrospective observational study aims to evaluate outcomes in adult patients undergoing cardiac surgery for infective endocarditis at the Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo of Alessandria. The primary objective is to assess 30-day mortality after surgery and to analyze clinical and surgical factors associated with adverse outcomes.

Secondary objectives include the description of epidemiological, clinical, microbiological, and therapeutic characteristics of surgically treated infective endocarditis, the identification of predictors of postoperative complications, and the evaluation of mortality and recurrence of infection at 6 and 12 months after surgery. The study also assesses the consistency between documented surgical indications and the recommendations of the European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.

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Key information

Conditions

Infective Endocarditis (IE) Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Cardiac Surgery

Alessandria, AL, 15121, Italy

About this study

Infective endocarditis (IE) remains a severe disease associated with high morbidity and mortality despite advances in antimicrobial therapy and cardiac surgery. Surgical treatment is often required in complicated cases, such as severe valvular dysfunction, uncontrolled infection, or high embolic risk.

IE is characterized by the formation of vegetations, defined as pathological masses composed of fibrin, platelets, white blood cells, and microorganisms. These lesions mainly involve native or prosthetic cardiac valves but may occasionally develop on other endocardial devices.The microorganisms most frequently responsible for complicated forms of infective endocarditis are typically aggressive pathogens or organisms with resistance to antimicrobial therapy. In recent years, the incidence of infective endocarditis appears to show a continuous increasing trend. This increase may be related to several factors, including the aging of the population, the growing use of implantable cardiac devices, and changes in antibiotic prophylaxis strategies. These epidemiological changes highlight the need for continuous evaluation and improvement of diagnostic and therapeutic strategies for a disease that remains associated with substantial morbidity and mortality.

This retrospective observational study includes all adult patients who underwent cardiac surgery for infective endocarditis between 2019 and 2024 at the University Hospital of Alessandria. The diagnosis of infective endocarditis is defined according to the modified Duke criteria and is retrospectively confirmed based on the available clinical documentation.

The study also evaluates the consistency between documented surgical indications and the recommendations of the current European Society of Cardiology (ESC) guidelines for the management of infective endocarditis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Patients admitted to the AOU AL and undergoing surgery between 2019 and 2024 for infectious endocarditis with ICD-9 diagnosis:

O 4210 -Acute and subacute bacterial endocarditis O 4211-Acute and subacute infectious endocarditis in diseases Classified elsewhere O 4219 -Unspecified acute endocarditis O 42490 -Endocarditis, unspecified valve, specify Specified O 42491 -Endocarditis in diseases classified elsewhere O 42499 -Other endocarditis, valves not specified

  • Signature of informed consent

Exclusion criteria

  • Incomplete medical records or records with data missing that is relevant to this study
  • Severely immunocompromised patients (e.g. organ transplant patients, patients undergoing intensive chemotherapy, patients with advanced AIDS, etc.)

Treatment and study plan

Data Collection

Other

Patients retrospectively enrolled who underwent surgery for infective endocarditis between 2019 and 2024.

Data are collected in a dedicated electronic database.

Primary outcomes

  1. 30-day mortality after cardiac surgery for infective endocarditis

    Time frame: Until the completion of the study, which is expected to last approximately 12 months.

    Evaluation of mortality occurring within 30 days after cardiac surgery for infective endocarditis.

Secondary outcomes

  1. Patient characteristics in complicated infective endocarditis

    Time frame: Until the completion of the study, which is expected to last approximately 12 months.

    Describe the characteristics of patients undergoing cardiac surgery for complicated infective endocarditis.

  2. Predictors of postoperative complications

    Time frame: Until the completion of the study, which is expected to last approximately 12 months.

    Identification of possible predictors of post-operative complications (infections, thromboembolic events, organ failure, need for reoperation) in patients undergoing cardiac surgery for infective endocarditis.

  3. Consistency of surgical indications with ESC guideline recommendations

    Time frame: Until the completion of the study, which is expected to last approximately 12 months.

    Assessment of the concordance between the surgical indications documented for patients with complicated infective endocarditis and the recommendations of the 2023 European Society of Cardiology (ESC) guidelines.

  4. Assessment of microorganisms

    Time frame: Until the completion of the study, which is expected to last approximately 12 months.

    Assessment of microorganisms based on antibiogram in relation to an increased probability of post-operative complications.

  5. All-cause mortality at 6 months

    Time frame: 6 months post-surgery.

    All-cause mortality within 6 months after cardiac surgery for complicated infective endocarditis.

  6. All-cause mortality at 12 months

    Time frame: 12 months post-surgery.

    All-cause mortality within 12 months after cardiac surgery for complicated infective endocarditis.

  7. Infectious recurrence at 6 months

    Time frame: 6 months post-surgery.

    Recurrence of infective endocarditis or related infection within 6 months after surgery.

  8. Infectious recurrence at 12 months

    Time frame: 12 months post-surgery.

    Recurrence of infective endocarditis or related infection within 12 months after surgery.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Registry information

Official study title

Outcomes of Surgical Treatment in Patients With Infective Endocarditis: a Retrospective Observational Study

Acronym: ETCEI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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