SURgical Registry of ENDocarditis EuRope

Not yet recruiting

• Conditions: Cardiac Surgery; Outcomes; Infective Endocarditis

• Registration Number: NCT05563662
• Lead Sponsor: University Hospital, Essen

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.

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Start: 2023-09
• Primary Completion: 2032-12
• Study Completion: 2033-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
MACCE at long term follow-up	1 to 5 years	Major adverse cardiac and cerebrovascular event rate at 1 to 5 years post-surgery
Sepsis accociated mortatilty	30 days or during index hospitalization	Sepsis accociated mortatilty at day 30 or during index hospitalization
Vasoactive inotropic score	< 72h post-surgery	The sum of maximum dose rates of inotropes and/or vasopressor medications administered the first 72h post-surgery
Mechanical ventilation time	30 days or during index hospitalization	Duration of postoperative invasive/mechanical ventilation post-surgery
Dialysis (RRT post-surgery)	30 days or during index hospitalization	Occurence of renal failure requiring renal replacement therapy
Readmission due to IE recurrence	30 days to 1 year post-surgery	Recurrence of infective endocarditis after 30 days to 1 year post-surgery
Post-operative sepsis	30 days or during index hospitalization	Sepsis at day 30 or during index hospitalization
Renal failure	30 days or during index hospitalization	Occurence of renal failure (KDIGO criteria)
MACCE	30 days or during index hospitalization	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)

Trial Locations

Locations (2)

Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University; 🇩🇪 Nürnberg, Bavaria, Germany

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