- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03266302
Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis (REMOVE)
April 7, 2022 updated by: Jena University Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
288
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bad Oeynhausen, Germany, 32545
- Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie
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Bernau bei Berlin, Germany, 16321
- Herzzentrum Brandenburg, Immanuel Klinikum Bernau
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Bochum, Germany, 44789
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie
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Bonn, Germany, 53127
- Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie
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Dresden, Germany, 01307
- Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie
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Düsseldorf, Germany, 40225
- Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie
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Halle (Saale), Germany, 06120
- Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie
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Leipzig, Germany, 04289
- Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie
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Baden-Württemberg
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Bad Krozingen, Baden-Württemberg, Germany, D-79189
- University Heart Center Bad Krozingen
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Freiburg, Baden-Württemberg, Germany, D-79106
- University Heart Center Freiburg
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Ulm, Baden-Württemberg, Germany, D-89081
- University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Germany, D-50937
- University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery
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Essen, North Rhine-Westphalia, Germany, D-45147
- University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery
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Thuringia
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Jena, Thuringia, Germany, 07747
- Jena University Hospital, Dept. of Cardiac and Thoracic Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
- informed consent
- age ≥18 years
Exclusion Criteria:
- EuroScoreII ≤ 3
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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)
|
Use of the hemoadsorber during cardiac surgery with CPB.
Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
Other Names:
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NO_INTERVENTION: 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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SOFA Score
Time Frame: 24 hours before until day 9 post-surgery
|
The investigators will test if mean SOFA scores are different for the experimental and control group.
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24 hours before until day 9 post-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall mortality rate
Time Frame: until day 30 post surgery
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Overall mortality rate until day 30 post-surgery
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until day 30 post surgery
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Changes in cytokine and cfDNA levels
Time Frame: 24 hours before, during cardiac surgery and 24 hours after surgery
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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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24 hours before, during cardiac surgery and 24 hours after surgery
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SOFA subscores
Time Frame: 24 hours before surgery until day 9 post-surgery
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single SOFA subscores will be analyzed
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24 hours before surgery until day 9 post-surgery
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Days on ventilator, vasopressor and renal replacement therapy
Time Frame: until day 30 post-surgery
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Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed
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until day 30 post-surgery
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incidence of stroke
Time Frame: until day 30 post-surgery
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incidence of stroke within 30 days post-surgery will be assessed
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until day 30 post-surgery
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length of ICU and in-hospital stay
Time Frame: until day 30 post-surgery
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total length of ICU and in-hospital stay until day 30 post-surgery
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until day 30 post-surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Mahmoud Diab, Dr., Jena University Hospital, Department of Cardiac and Thoracic Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 17, 2018
Primary Completion (ACTUAL)
February 28, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
August 28, 2017
First Submitted That Met QC Criteria
August 29, 2017
First Posted (ACTUAL)
August 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 8, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZKSJ0108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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