SURgical Registry of ENDocarditis EuRope

NCT ID: NCT05563662

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2033-04-30

Brief Summary

This is a prospective, multicentric, european registry of patients with infective endocarditis undergoing cardiac surgery. Patient demographics, clinical data and laboratory values will be collected, as well as treatment outcomes at day 30, day 90 and 1-5 years after the intervention.

Detailed Description

Infective endocarditis (IE) is now a relatively rare but worldwide disease (3-10 IE/100000 population/year) with increasing incidence especially in the Western world. IE is still associated with high morbidity and mortality, prolonged hospital stay, high risk of reinfection, significantly worsened prognosis for patients, substantially reduced quality of life, and in any case represents a major financial burden for the respective healthcare systems [1-11].

Patients who need to undergo cardiac surgery due to infective endocarditis (IE) are heterogeneous and present with a persistently high perioperative morbidity and mortality rate. Despite optimal and individualized perioperative management strategies, perioperative complications such as heart failure, systemic inflammatory response, vasoplegia, and sepsis is still the main reason for adverse outcomes following cardiac surgery.

The present European, multicenter IE registry (Surgical RegistRy of infective ENDocarditis in EuRope - SURRENDER) was initiated and established to record and appropriately analyze current surgical treatment options and perioperative adjunctive treatment strategies, as well as short- and long-term patient outcomes.

Conditions

Infective Endocarditis; Cardiac Surgery; Outcomes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cardiac surgery

Patients with infective endocarditis undergoing open heart surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
• Age ≥18 years
• Written informed consent

Exclusion Criteria

• Age < 18 years
• Missing declaration of consent
• Current participation in another interventional trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Matthias Thielmann

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Thielmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic and Cardiovascular Surgery, University Hospital Essen

Jurij Kalisnik, PD. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University

Locations

Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University

Nuremberg, Bavaria, Germany

University Hospital Essen, Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center, University Duisburg-Essen

Essen, , Germany

Countries

Germany

Central Contacts

Matthias Thielmann, Prof. Dr.

Role: CONTACT

matthias.thielmann@uk-essen.de

+49-201-723-84908

Wolfgang Ristau

Role: CONTACT

wolfgang.ristau@uk-essen.de

+49-201-723-84927

Facility Contacts

Jurij Kalisnik, PD Dr.

Role: primary

Jurij.Kalisnik@klinikum-nuernberg.de

Matthias Thielmann, Prof.

Role: primary

matthias.thielmann@uk-essen.de

+49-201-723-84908

Wolfgang Ristau

Role: backup

wolfgang.ristau@uk-essen.de

+49-201-723-84927

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Other Identifiers

WDHZ-TC-SURRENDER

Identifier Type: -

Identifier Source: org_study_id