SURgical Registry of ENDocarditis EuRope

Официальное название

SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Cardiac surgery
  Patients with infective endocarditis undergoing open heart surgery

Первичные конечные точки

• In-hospital mortality (all cause) [Срок оценки: 30 days or during index hospitalization]
• Mortality at long-term follow-up [Срок оценки: 1 to 5 years]

Вторичные конечные точки (9)

• MACCE [Срок оценки: 30 days or during index hospitalization]
• MACCE at long term follow-up [Срок оценки: 1 to 5 years]
• Sepsis accociated mortatilty [Срок оценки: 30 days or during index hospitalization]
• Post-operative sepsis [Срок оценки: 30 days or during index hospitalization]
• Vasoactive inotropic score [Срок оценки: < 72h post-surgery]
• Mechanical ventilation time [Срок оценки: 30 days or during index hospitalization]
• Readmission due to IE recurrence [Срок оценки: 30 days to 1 year post-surgery]
• Renal failure [Срок оценки: 30 days or during index hospitalization]
• Dialysis (RRT post-surgery) [Срок оценки: 30 days or during index hospitalization]

Критерии участия

Критерии включения

• Patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
• Age ≥18 years
• Written informed consent

Критерии исключения

• Age < 18 years
• Missing declaration of consent
• Current participation in another interventional trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 2 центра

• Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University — Nuremberg
• University Hospital Essen, Department of Thoracic and Cardiovascular Surgery, West-German — Essen

Публикации

• Thornhill MH, Dayer MJ, Nicholl J, Prendergast BD, Lockhart PB, Baddour LM. An alarming rise in incidence of infective endocarditis in England since 2009: why? Lancet. 2020 Apr 25;395(10233):1325-1327. doi: 10.1016/S0140-6736(20)30530-4. No abstract available. PMID 32334690
• Olmos C, Vilacosta I, Fernandez-Perez C, Bernal JL, Ferrera C, Garcia-Arribas D, Perez-Garcia CN, San Roman JA, Maroto L, Macaya C, Elola FJ. The Evolving Nature of Infective Endocarditis in Spain: A Population-Based Study (2003 to 2014). J Am Coll Cardiol. 2017 Dec 5;70(22):2795-2804. doi: 10.1016/j.jacc.2017.10.005. PMID 29191329
• Habib G, Erba PA, Iung B, Donal E, Cosyns B, Laroche C, Popescu BA, Prendergast B, Tornos P, Sadeghpour A, Oliver L, Vaskelyte JJ, Sow R, Axler O, Maggioni AP, Lancellotti P; EURO-ENDO Investigators. Clinical presentation, aetiology and outcome of infective endocarditis. Results of the ESC-EORP EURO-ENDO (European infective endocarditis) registry: a prospective cohort study. Eur Heart J. 2019 Oct PMID 31504413
• Becher PM, Gossling A, Fluschnik N, Schrage B, Seiffert M, Schofer N, Blankenberg S, Kirchhof P, Westermann D, Kalbacher D. Temporal trends in incidence, patient characteristics, microbiology and in-hospital mortality in patients with infective endocarditis: a contemporary analysis of 86,469 cases between 2007 and 2019. Clin Res Cardiol. 2024 Feb;113(2):205-215. doi: 10.1007/s00392-022-02100-4. Ep PMID 36094574
• Sy RW, Kritharides L. Health care exposure and age in infective endocarditis: results of a contemporary population-based profile of 1536 patients in Australia. Eur Heart J. 2010 Aug;31(15):1890-7. doi: 10.1093/eurheartj/ehq110. Epub 2010 May 7. PMID 20453066
• Heiro M, Helenius H, Hurme S, Savunen T, Metsarinne K, Engblom E, Nikoskelainen J, Kotilainen P. Long-term outcome of infective endocarditis: a study on patients surviving over one year after the initial episode treated in a Finnish teaching hospital during 25 years. BMC Infect Dis. 2008 Apr 17;8:49. doi: 10.1186/1471-2334-8-49. PMID 18419812
• Mylonakis E, Calderwood SB. Infective endocarditis in adults. N Engl J Med. 2001 Nov 1;345(18):1318-30. doi: 10.1056/NEJMra010082. No abstract available. PMID 11794152
• Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery PMID 26373316

Идентификаторы

NCT: NCT05563662 · WDHZ-TC-SURRENDER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗