Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis
NCT ID: NCT03266302
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
288 participants
INTERVENTIONAL
2018-01-17
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
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Interventional group
Use of hemoadsorber for removal of cytokines. Participants undergoing cardiac surgery due to infective endocarditis will be treated using a hemoadsorption device (CytoSorb) within the cardiopulmonary Bypass circuit (=Intervention)
hemoadsorber for removal of cytokines
Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
Control group
Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)
No interventions assigned to this group
Interventions
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hemoadsorber for removal of cytokines
Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* informed consent
* age ≥18 years
Exclusion Criteria
* current participation in another interventional Trial
* pregnancy
* current immunosuppressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold)
* previous participation in the REMOVE study
18 Years
ALL
No
Sponsors
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CytoSorbents, Inc
INDUSTRY
Thermo Fisher Scientific, Inc
INDUSTRY
Fraunhofer Institute for Interfacial Engineering and Biotechnology
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
Jena University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mahmoud Diab, Dr.
Role: STUDY_DIRECTOR
Jena University Hospital, Department of Cardiac and Thoracic Surgery
Locations
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University Heart Center Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
University Heart Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery
Ulm, Baden-Wurttemberg, Germany
University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery
Cologne, North Rhine-Westphalia, Germany
University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery
Essen, North Rhine-Westphalia, Germany
Jena University Hospital, Dept. of Cardiac and Thoracic Surgery
Jena, Thuringia, Germany
Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie
Bad Oeynhausen, , Germany
Herzzentrum Brandenburg, Immanuel Klinikum Bernau
Bernau bei Berlin, , Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie
Bochum, , Germany
Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie
Bonn, , Germany
Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie
Dresden, , Germany
Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie
Düsseldorf, , Germany
Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie
Halle, , Germany
Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie
Leipzig, , Germany
Countries
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References
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Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.
Brunkhorst FM, Oppert M, Marx G, Bloos F, Ludewig K, Putensen C, Nierhaus A, Jaschinski U, Meier-Hellmann A, Weyland A, Grundling M, Moerer O, Riessen R, Seibel A, Ragaller M, Buchler MW, John S, Bach F, Spies C, Reill L, Fritz H, Kiehntopf M, Kuhnt E, Bogatsch H, Engel C, Loeffler M, Kollef MH, Reinhart K, Welte T; German Study Group Competence Network Sepsis (SepNet). Effect of empirical treatment with moxifloxacin and meropenem vs meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial. JAMA. 2012 Jun 13;307(22):2390-9. doi: 10.1001/jama.2012.5833.
Bustamante J, Arevalo A, Tamayo E, Sarria C, Aguilar-Blanco EM, Heredia M, Almansa R, Rico L, Iglesias V, Bermejo-Martin JF. Cytokine profiles linked to fatal outcome in infective prosthetic valve endocarditis. APMIS. 2014 Jun;122(6):526-9. doi: 10.1111/apm.12189. Epub 2013 Sep 30.
Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. doi: 10.1016/s0003-4975(96)01061-2.
Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.
Minne L, Abu-Hanna A, de Jonge E. Evaluation of SOFA-based models for predicting mortality in the ICU: A systematic review. Crit Care. 2008;12(6):R161. doi: 10.1186/cc7160. Epub 2008 Dec 17.
Prendergast BD, Tornos P. Surgery for infective endocarditis: who and when? Circulation. 2010 Mar 9;121(9):1141-52. doi: 10.1161/CIRCULATIONAHA.108.773598. No abstract available.
Diab M, Lehmann T, Bothe W, Akhyari P, Platzer S, Wendt D, Deppe AC, Strauch J, Hagel S, Gunther A, Faerber G, Sponholz C, Franz M, Scherag A, Velichkov I, Silaschi M, Fassl J, Hofmann B, Lehmann S, Schramm R, Fritz G, Szabo G, Wahlers T, Matschke K, Lichtenberg A, Pletz MW, Gummert JF, Beyersdorf F, Hagl C, Borger MA, Bauer M, Brunkhorst FM, Doenst T; REMOVE Trial Investigators*. Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial. Circulation. 2022 Mar 29;145(13):959-968. doi: 10.1161/CIRCULATIONAHA.121.056940. Epub 2022 Feb 25.
Diab M, Platzer S, Guenther A, Sponholz C, Scherag A, Lehmann T, Velichkov I, Hagel S, Bauer M, Brunkhorst FM, Doenst T. Assessing efficacy of CytoSorb haemoadsorber for prevention of organ dysfunction in cardiac surgery patients with infective endocarditis: REMOVE-protocol for randomised controlled trial. BMJ Open. 2020 Mar 30;10(3):e031912. doi: 10.1136/bmjopen-2019-031912.
Other Identifiers
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ZKSJ0108
Identifier Type: -
Identifier Source: org_study_id
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