SURgical Registry of ENDocarditis EuRope

Cardiac Surgery Clinical Trial

— SURRENDER  

Official title:

SURgical Registry of Infective ENDocarditis in EuRope - SURRENDER

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05563662
• Other study ID #: WDHZ-TC-SURRENDER
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: April 2033

Study information

• Verified date: May 2023
• Source: University Hospital, Essen
• Contact: Matthias Thielmann, Prof. Dr.
• Phone: +49-201-723-84908
• Email: matthias.thielmann[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: April 2033
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis
• Outcomes

Intervention

Procedure:
• Cardiac surgery
Patients with infective endocarditis undergoing open heart surgery

Locations

Country	Name	City	State
Germany	University Hospital Essen, Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center, University Duisburg-Essen	Essen
Germany	Department of Cardiac Surgery, Hospital Nürnberg, Paracelsus Medical University	Nürnberg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (11)

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 and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15. Erratum In: Circulation. 2015 Oct 27;132(17):e215. Circulation. 2016 Aug 23;134(8):e113. Circulation. 2018 Jul 31;138(5):e78-e79. — View Citation

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. 2022 Sep 12. doi: 10.1007/s00392-022-02100-4. Online ahead of print. — View Citation

Bonaros N, Czerny M, Pfausler B, Muller S, Bartel T, Thielmann M, Shehada SE, Folliguet T, Obadia JF, Holfeld J, Lorusso R, Parolari A, Muller L, Grimm M, Ruttmann-Ulmer E. Infective endocarditis and neurologic events: indications and timing for surgical interventions. Eur Heart J Suppl. 2020 Dec 6;22(Suppl M):M19-M25. doi: 10.1093/eurheartj/suaa167. eCollection 2020 Nov. — View Citation

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 14;40(39):3222-3232. doi: 10.1093/eurheartj/ehz620. Erratum In: Eur Heart J. 2020 Jun 7;41(22):2091. — View Citation

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. — View Citation

Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4. Erratum In: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tleyjeh IM, Steckelberg JM, Murad HS, Anavekar NS, Ghomrawi HM, Mirzoyev Z, Moustafa SE, Hoskin TL, Mandrekar JN, Wilson WR, Baddour LM. Temporal trends in infective endocarditis: a population-based study in Olmsted County, Minnesota. JAMA. 2005 Jun 22;293(24):3022-8. doi: 10.1001/jama.293.24.3022. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality (all cause)	Overall mortality rate in-hospital, at day 30 or during index hospitalization	30 days or during index hospitalization
Primary	Mortality at long-term follow-up	at 1 to 5 years post-surgery	1 to 5 years
Secondary	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)	30 days or during index hospitalization
Secondary	MACCE at long term follow-up	Major adverse cardiac and cerebrovascular event rate at 1 to 5 years post-surgery	1 to 5 years
Secondary	Sepsis accociated mortatilty	Sepsis accociated mortatilty at day 30 or during index hospitalization	30 days or during index hospitalization
Secondary	Post-operative sepsis	Sepsis at day 30 or during index hospitalization	30 days or during index hospitalization
Secondary	Vasoactive inotropic score	The sum of maximum dose rates of inotropes and/or vasopressor medications administered the first 72h post-surgery	< 72h post-surgery
Secondary	Mechanical ventilation time	Duration of postoperative invasive/mechanical ventilation post-surgery	30 days or during index hospitalization
Secondary	Readmission due to IE recurrence	Recurrence of infective endocarditis after 30 days to 1 year post-surgery	30 days to 1 year post-surgery
Secondary	Renal failure	Occurence of renal failure (KDIGO criteria)	30 days or during index hospitalization
Secondary	Dialysis (RRT post-surgery)	Occurence of renal failure requiring renal replacement therapy	30 days or during index hospitalization