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NCT Number: NCT05563662

SURgical Registry of ENDocarditis EuRope

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University, Nuremberg, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

Patients with infective endocarditis undergoing open heart surgery

Primary outcomes

  1. In-hospital mortality (all cause)

    Time frame: 30 days or during index hospitalization

    Overall mortality rate in-hospital, at day 30 or during index hospitalization

  2. Mortality at long-term follow-up

    Time frame: 1 to 5 years

    at 1 to 5 years post-surgery

Secondary outcomes

  1. MACCE

    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)

  2. MACCE at long term follow-up

    Time frame: 1 to 5 years

    Major adverse cardiac and cerebrovascular event rate at 1 to 5 years post-surgery

  3. Sepsis accociated mortatilty

    Time frame: 30 days or during index hospitalization

    Sepsis accociated mortatilty at day 30 or during index hospitalization

  4. Post-operative sepsis

    Time frame: 30 days or during index hospitalization

    Sepsis at day 30 or during index hospitalization

  5. Vasoactive inotropic score

    Time frame: < 72h post-surgery

    The sum of maximum dose rates of inotropes and/or vasopressor medications administered the first 72h post-surgery

  6. Mechanical ventilation time

    Time frame: 30 days or during index hospitalization

    Duration of postoperative invasive/mechanical ventilation post-surgery

  7. Readmission due to IE recurrence

    Time frame: 30 days to 1 year post-surgery

    Recurrence of infective endocarditis after 30 days to 1 year post-surgery

  8. Renal failure

    Time frame: 30 days or during index hospitalization

    Occurence of renal failure (KDIGO criteria)

  9. Dialysis (RRT post-surgery)

    Time frame: 30 days or during index hospitalization

    Occurence of renal failure requiring renal replacement therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Matthias Thielmann, Prof. Dr.

CONTACT

[email protected]

+49-201-723-84908

Wolfgang Ristau

CONTACT

[email protected]

+49-201-723-84927

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER

Acronym: SURRENDER

Important dates

Study start
2023
Primary completion
2032
Study completion
2033
First posted
Oct 3, 2022
Registry last updated
May 10, 2023

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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