An observational study in Infective Endocarditis, Cardiac Surgery and Outcomes, sponsored by University Hospital, Essen. Not yet recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University Hospital, Essen · Observational
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.
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →University Hospital, Essen is the lead sponsor of 118 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with infective endocarditis undergoing open heart surgery with cardio-pulmonary bypass
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with infective endocarditis undergoing open heart surgery
In-hospital mortality (all cause)
Overall mortality rate in-hospital, at day 30 or during index hospitalization
Time frame: 30 days or during index hospitalization
Mortality at long-term follow-up
at 1 to 5 years post-surgery
Time frame: 1 to 5 years
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)
Time frame: 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
Time frame: 1 to 5 years
Sepsis accociated mortatilty
Sepsis accociated mortatilty at day 30 or during index hospitalization
Time frame: 30 days or during index hospitalization
Post-operative sepsis
Sepsis at day 30 or during index hospitalization
Time frame: 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
Time frame: < 72h post-surgery
Mechanical ventilation time
Duration of postoperative invasive/mechanical ventilation post-surgery
Time frame: 30 days or during index hospitalization
Readmission due to IE recurrence
Recurrence of infective endocarditis after 30 days to 1 year post-surgery
Time frame: 30 days to 1 year post-surgery
Renal failure
Occurence of renal failure (KDIGO criteria)
Time frame: 30 days or during index hospitalization
Dialysis (RRT post-surgery)
Occurence of renal failure requiring renal replacement therapy
Time frame: 30 days or during index hospitalization
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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