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SURgical Registry of ENDocarditis EuRope

SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05563662
Acronym
SURRENDER
Enrollment
10000
Registered
2022-10-03
Start date
2023-09-30
Completion date
2033-04-30
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Infective Endocarditis, Outcomes

Keywords

Infective Endocarditis, Registry, European, Surgery, Prognosis

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.

Interventions

PROCEDURECardiac surgery

Patients with infective endocarditis undergoing open heart surgery

Sponsors

University Hospital, Essen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality (all cause)30 days or during index hospitalizationOverall mortality rate in-hospital, at day 30 or during index hospitalization
Mortality at long-term follow-up1 to 5 yearsat 1 to 5 years post-surgery

Secondary

MeasureTime frameDescription
Sepsis accociated mortatilty30 days or during index hospitalizationSepsis accociated mortatilty at day 30 or during index hospitalization
Post-operative sepsis30 days or during index hospitalizationSepsis at day 30 or during index hospitalization
Vasoactive inotropic score< 72h post-surgeryThe sum of maximum dose rates of inotropes and/or vasopressor medications administered the first 72h post-surgery
MACCE30 days or during index hospitalizationMajor 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)
Readmission due to IE recurrence30 days to 1 year post-surgeryRecurrence of infective endocarditis after 30 days to 1 year post-surgery
Renal failure30 days or during index hospitalizationOccurence of renal failure (KDIGO criteria)
Dialysis (RRT post-surgery)30 days or during index hospitalizationOccurence of renal failure requiring renal replacement therapy
Mechanical ventilation time30 days or during index hospitalizationDuration of postoperative invasive/mechanical ventilation post-surgery
MACCE at long term follow-up1 to 5 yearsMajor adverse cardiac and cerebrovascular event rate at 1 to 5 years post-surgery

Countries

Germany

Contacts

Primary ContactMatthias Thielmann, Prof. Dr.
matthias.thielmann@uk-essen.de+49-201-723-84908
Backup ContactWolfgang Ristau
wolfgang.ristau@uk-essen.de+49-201-723-84927

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026