SURgical Registry of ENDocarditis EuRope

Study Overview
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Brief Summary
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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
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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.

Official Title
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SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER

Conditions
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Infective Endocarditis, Cardiac Surgery, Outcomes

Intervention / Treatment
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* Procedure: Cardiac surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac surgery|Patients with infective endocarditis undergoing open heart surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality (all cause) | Overall mortality rate in-hospital, at day 30 or during index hospitalization | 30 days or during index hospitalization | 
| Mortality at long-term follow-up | at 1 to 5 years post-surgery | 1 to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Major adverse cardiac and cerebrovascular event rate at day 30 or during index hospitalization. Composite of 1.) Cardiac events: (postoperative myocardial infarction, CPR, LCOS/heart failure, repeat cardiac surgery) and/or cerebrovascular events (postoperative stroke, TIA, intracranial hemorrhage) | 30 days or during index hospitalization | 
| MACCE at long term follow-up | Major adverse cardiac and cerebrovascular event rate at 1 to 5 years post-surgery | 1 to 5 years | 
| Sepsis accociated mortatilty | Sepsis accociated mortatilty at day 30 or during index hospitalization | 30 days or during index hospitalization | 
| Post-operative sepsis | Sepsis at day 30 or during index hospitalization | 30 days or during index hospitalization | 
| Vasoactive inotropic score | The sum of maximum dose rates of inotropes and/or vasopressor medications administered the first 72h post-surgery | < 72h post-surgery | 
| Mechanical ventilation time | Duration of postoperative invasive/mechanical ventilation post-surgery | 30 days or during index hospitalization | 
| Readmission due to IE recurrence | Recurrence of infective endocarditis after 30 days to 1 year post-surgery | 30 days to 1 year post-surgery | 
| Renal failure | Occurence of renal failure (KDIGO criteria) | 30 days or during index hospitalization | 
| Dialysis (RRT post-surgery) | Occurence of renal failure requiring renal replacement therapy | 30 days or during index hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infective Endocarditis, Registry, European, Surgery, Prognosis