European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE)

August 5, 2025 updated by: Giuseppe Gatti, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE)

The European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE) is a nascent large surgical registry that would encompass most relevant aspects of IE in Europe in the contemporary era.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

ERGOSTE, Purposes:

  • To create a European multicenter retrospective database including a large number of patients undergoing surgical treatment for infective endocarditis (IE).
  • To perform epidemiologic analyses of IE-patients and involved pathogens.
  • To find independent predictors of early post-operative death.
  • To test ALL the scoring systems specifically developed to predict early death after surgery for infective endocarditis.
  • To devise a specific risk score for early postoperative death.
  • To explore early and late outcomes of these very difficult patients in order to establish optimal indications, techniques and timing of surgery.
  • To carry out a number of sub-analyses concerning the demographic parameters and variable clinical presentation of patients, type and severity of cardiac structural involvement, adopted valve prostheses and surgical techniques, and different involved microbiologic agents.
  • To lay experiential foundations of a prospective database on the topic.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

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

Study Locations

  • Italy
      • Trieste, Italy, 34151
        • Cardiac Surgery Unit - ASUGI

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

Probability Sample

Study Population

Patients undergoing cardiac surgery due to infective endocarditis

Description

Inclusion Criteria:

  • Patients undergoing cardiac surgery due to infective endocarditis

Exclusion Criteria:

  • Patients under 18 years

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early post-operative mortality
Time Frame: Mortality at 1 year after surgery
Mortality at 1 year after surgery

Collaborators and Investigators

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

Sponsor

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

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 (Actual)

June 1, 2025

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

July 16, 2025

First Submitted That Met QC Criteria

August 5, 2025

First Posted (Actual)

August 7, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 386_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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