Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-06-25 @ 1:41 AM
Study NCT ID:
NCT03266302
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will not be informed about group allocation'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 288}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOFA Score', 'timeFrame': '24 hours before until day 9 post-surgery', 'description': 'The investigators will test if mean SOFA scores are different for the experimental and control group.'}], 'secondaryOutcomes': [{'measure': 'Overall mortality rate', 'timeFrame': 'until day 30 post surgery', 'description': 'Overall mortality rate until day 30 post-surgery'}, {'measure': 'Changes in cytokine and cfDNA levels', 'timeFrame': '24 hours before, during cardiac surgery and 24 hours after surgery', 'description': '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'}, {'measure': 'SOFA subscores', 'timeFrame': '24 hours before surgery until day 9 post-surgery', 'description': 'single SOFA subscores will be analyzed'}, {'measure': 'Days on ventilator, vasopressor and renal replacement therapy', 'timeFrame': 'until day 30 post-surgery', 'description': 'Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed'}, {'measure': 'incidence of stroke', 'timeFrame': 'until day 30 post-surgery', 'description': 'incidence of stroke within 30 days post-surgery will be assessed'}, {'measure': 'length of ICU and in-hospital stay', 'timeFrame': 'until day 30 post-surgery', 'description': 'total length of ICU and in-hospital stay until day 30 post-surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vasodilatory shock', 'hemoadsorption', 'cardiac surgery', 'cytokines'], 'conditions': ['Infective Endocarditis']}, 'referencesModule': {'references': [{'pmid': '27059056', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22692171', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24106887', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8993292', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12519925', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19091120', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20212293', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35213213', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32234739', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery\n* informed consent\n* age ≥18 years\n\nExclusion Criteria:\n\n* EuroScoreII ≤ 3\n* current participation in another interventional Trial\n* pregnancy\n* current immunosuppressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold)\n* previous participation in the REMOVE study'}, 'identificationModule': {'nctId': 'NCT03266302', 'acronym': 'REMOVE', 'briefTitle': 'Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - a Multicentric Randomized Controlled Group Sequential Trial', 'orgStudyIdInfo': {'id': 'ZKSJ0108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': '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)', 'interventionNames': ['Device: hemoadsorber for removal of cytokines']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)'}], 'interventions': [{'name': 'hemoadsorber for removal of cytokines', 'type': 'DEVICE', 'otherNames': ['CytoSorb(R)'], 'description': "Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.", 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-79189', 'city': 'Bad Krozingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Heart Center Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': 'D-79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Heart Center Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': 'D-89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': 'D-50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'D-45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Jena University Hospital, Dept. of Cardiac and Thoracic Surgery', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '16321', 'city': 'Bernau bei Berlin', 'country': 'Germany', 'facility': 'Herzzentrum Brandenburg, Immanuel Klinikum Bernau', 'geoPoint': {'lat': 52.67982, 'lon': 13.58708}}, {'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Mahmoud Diab, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jena University Hospital, Department of Cardiac and Thoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'CytoSorbents, Inc', 'class': 'INDUSTRY'}, {'name': 'Thermo Fisher Scientific, Inc', 'class': 'INDUSTRY'}, {'name': 'Fraunhofer Institute for Interfacial Engineering and Biotechnology', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}