Outcomes of Surgical Treatment in Patients With Infective Endocarditis

NCT07529730 | Completed

• 1 other identifier: ASO.Cch.25.02
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infective Endocarditis (IE)

Outcome Measures

Primary Outcomes (1)

• 30-day mortality after cardiac surgery for infective endocarditis

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

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

Secondary Outcomes (8)

• Patient characteristics in complicated infective endocarditis

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

• Predictors of postoperative complications

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

• Consistency of surgical indications with ESC guideline recommendations

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

• Assessment of microorganisms

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

• All-cause mortality at 6 months

  6 months post-surgery.

Study Arms (1)

Infective endocarditis (IE)

Patients who have undergone surgery for infective endocarditis

Other: Data collection

Interventions

Data collection OTHER

Patients retrospectively enrolled who underwent surgery for infective endocarditis between 2019 and 2024. Data are collected in a dedicated electronic database.

Infective endocarditis (IE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent surgery for infective endocarditis between 2019 and 2024

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead

Study Sites (1)

SC Cardiac Surgery

Alessandria, AL, 15121, Italy

Location

MeSH Terms

Conditions

Endocarditis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: April 16, 2025
• Primary Completion: October 23, 2025
• Study Completion: December 31, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)