Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis (REMOVE)
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ClinicalTrials.gov Identifier: NCT03266302 |
Recruitment Status :
Completed
First Posted : August 30, 2017
Last Update Posted : March 4, 2020
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Condition or disease | Intervention/treatment | Phase |
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Infective Endocarditis | Device: hemoadsorber for removal of cytokines | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 288 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety |
Masking: | Single (Participant) |
Masking Description: | Participant will not be informed about group allocation |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | January 17, 2018 |
Actual Primary Completion Date : | February 28, 2020 |
Actual Study Completion Date : | February 28, 2020 |

Arm | Intervention/treatment |
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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)
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Device: 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 Name: CytoSorb(R) |
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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- 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.
- Overall mortality rate [ Time Frame: until day 30 post surgery ]Overall mortality rate until day 30 post-surgery
- Changes in cytokine and cfDNA levels [ Time Frame: 24 hours before, during cardiac surgery and 24 hours after surgery ]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
- SOFA subscores [ Time Frame: 24 hours before surgery until day 9 post-surgery ]single SOFA subscores will be analyzed
- Days on ventilator, vasopressor and renal replacement therapy [ Time Frame: until day 30 post-surgery ]Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed
- incidence of stroke [ Time Frame: until day 30 post-surgery ]incidence of stroke within 30 days post-surgery will be assessed
- length of ICU and in-hospital stay [ Time Frame: until day 30 post-surgery ]total length of ICU and in-hospital stay until day 30 post-surgery

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266302
Germany | |
University Heart Center Bad Krozingen | |
Bad Krozingen, Baden-Württemberg, Germany, D-79189 | |
University Heart Center Freiburg | |
Freiburg, Baden-Württemberg, Germany, D-79106 | |
University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery | |
Ulm, Baden-Württemberg, Germany, D-89081 | |
University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery | |
Cologne, North Rhine-Westphalia, Germany, D-50937 | |
University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery | |
Essen, North Rhine-Westphalia, Germany, D-45147 | |
Jena University Hospital, Dept. of Cardiac and Thoracic Surgery | |
Jena, Thuringia, Germany, 07747 | |
Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie | |
Bad Oeynhausen, Germany, 32545 | |
Herzzentrum Brandenburg, Immanuel Klinikum Bernau | |
Bernau bei Berlin, Germany, 16321 | |
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie | |
Bochum, Germany, 44789 | |
Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie | |
Bonn, Germany, 53127 | |
Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie | |
Dresden, Germany, 01307 | |
Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie | |
Düsseldorf, Germany, 40225 | |
Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie | |
Halle (Saale), Germany, 06120 | |
Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie | |
Leipzig, Germany, 04289 |
Study Director: | Mahmoud Diab, Dr. | Jena University Hospital, Department of Cardiac and Thoracic Surgery |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jena University Hospital |
ClinicalTrials.gov Identifier: | NCT03266302 |
Other Study ID Numbers: |
ZKSJ0108 |
First Posted: | August 30, 2017 Key Record Dates |
Last Update Posted: | March 4, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
vasodilatory shock hemoadsorption cardiac surgery cytokines |
Endocarditis, Bacterial Endocarditis Heart Diseases Cardiovascular Diseases |
Bacterial Infections Cardiovascular Infections Infection |