cardiac surgery
ProcedurePatients with infective endocarditis undergoing open heart surgery
NCT Number: NCT05563662
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University, Nuremberg, Bavaria, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with infective endocarditis undergoing open heart surgery
Time frame: 30 days or during index hospitalization
Overall mortality rate in-hospital, at day 30 or during index hospitalization
Time frame: 1 to 5 years
at 1 to 5 years post-surgery
Time frame: 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)
Time frame: 1 to 5 years
Major adverse cardiac and cerebrovascular event rate at 1 to 5 years post-surgery
Time frame: 30 days or during index hospitalization
Sepsis accociated mortatilty at day 30 or during index hospitalization
Time frame: 30 days or during index hospitalization
Sepsis at day 30 or during index hospitalization
Time frame: < 72h post-surgery
The sum of maximum dose rates of inotropes and/or vasopressor medications administered the first 72h post-surgery
Time frame: 30 days or during index hospitalization
Duration of postoperative invasive/mechanical ventilation post-surgery
Time frame: 30 days to 1 year post-surgery
Recurrence of infective endocarditis after 30 days to 1 year post-surgery
Time frame: 30 days or during index hospitalization
Occurence of renal failure (KDIGO criteria)
Time frame: 30 days or during index hospitalization
Occurence of renal failure requiring renal replacement therapy
Contact information is provided by the study sponsor or research team.
Matthias Thielmann, Prof. Dr.
CONTACT
Wolfgang Ristau
CONTACT
University Hospital, Essen
Other
SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER
Acronym: SURRENDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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