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| Name | Class |
|---|---|
| CytoSorbents, Inc | INDUSTRY |
| Thermo Fisher Scientific, Inc | INDUSTRY |
| Fraunhofer Institute for Interfacial Engineering and Biotechnology | OTHER |
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Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.
The investigators assume a common standard deviation of 3.8 points and that a 1.4-point lower SOFA score in the Intervention Group is of clinical relevance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | 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) |
|
| Control group | No Intervention | Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemoadsorber for removal of cytokines | Device | Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation. |
| Measure | Description | Time Frame |
|---|---|---|
| SOFA Score | The investigators will test if mean SOFA scores are different for the experimental and control group. | 24 hours before until day 9 post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality rate | Overall mortality rate until day 30 post-surgery | until day 30 post surgery |
| Changes in cytokine and cfDNA levels | changes in cytokine and cfDNA levels will be measured at different time points before, during and after surgery in both groups; only for the first 2x25 patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Diab, Dr. | Jena University Hospital, Department of Cardiac and Thoracic Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Heart Center Bad Krozingen | Bad Krozingen | Baden-Wurttemberg | D-79189 | Germany | ||
| University Heart Center Freiburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27059056 | Background | 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. | |
| 22692171 |
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| German Federal Ministry of Education and Research |
| OTHER_GOV |
two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety
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Participant will not be informed about group allocation
|
| 24 hours before, during cardiac surgery and 24 hours after surgery |
| SOFA subscores | single SOFA subscores will be analyzed | 24 hours before surgery until day 9 post-surgery |
| Days on ventilator, vasopressor and renal replacement therapy | Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed | until day 30 post-surgery |
| incidence of stroke | incidence of stroke within 30 days post-surgery will be assessed | until day 30 post-surgery |
| length of ICU and in-hospital stay | total length of ICU and in-hospital stay until day 30 post-surgery | until day 30 post-surgery |
| Freiburg im Breisgau |
| Baden-Wurttemberg |
| D-79106 |
| Germany |
| University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery | Ulm | Baden-Wurttemberg | D-89081 | Germany |
| University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery | Cologne | North Rhine-Westphalia | D-50937 | Germany |
| University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery | Essen | North Rhine-Westphalia | D-45147 | Germany |
| Jena University Hospital, Dept. of Cardiac and Thoracic Surgery | Jena | Thuringia | 07747 | Germany |
| Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie | Bad Oeynhausen | 32545 | Germany |
| Herzzentrum Brandenburg, Immanuel Klinikum Bernau | Bernau bei Berlin | 16321 | Germany |
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie | Bochum | 44789 | Germany |
| Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie | Bonn | 53127 | Germany |
| Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie | Düsseldorf | 40225 | Germany |
| Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie | Halle | 06120 | Germany |
| Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie | Leipzig | 04289 | Germany |
| 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. |
| 24106887 | Background | 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. |
| 8993292 | Background | 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. |
| 12519925 | Background | 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. |
| 19091120 | Background | 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. |
| 20212293 | Background | 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. |
| 35213213 | Result | 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. |
| 32234739 | Derived | 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. |
| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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