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Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis (REMOVE)

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ClinicalTrials.gov Identifier: NCT03266302
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
CytoSorbents, Inc
B.R.A.H.M.S. (part of ThermoFisher Scientific)
Fraunhofer Institute for Interfacial Engineering and Biotechnology
German Federal Ministry of Education and Research (BMBF)
Information provided by (Responsible Party):
Jena University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Infective Endocarditis Device: hemoadsorber for removal of cytokines

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  (Clinical Trial)
Estimated Enrollment : 250 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall mortality rate [ Time Frame: until day 30 post surgery ]
    Overall mortality rate until day 30 post-surgery

  2. 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

  3. SOFA subscores [ Time Frame: 24 hours before surgery until day 9 post-surgery ]
    single SOFA subscores will be analyzed

  4. 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

  5. incidence of stroke [ Time Frame: until day 30 post-surgery ]
    incidence of stroke within 30 days post-surgery will be assessed

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
  • informed consent
  • age ≥18 years and ≤80 years

Exclusion Criteria:

  • EuroScoreII ≤ 3
  • current participation in another interventional Trial
  • pregnancy
  • current immunosuppressive or immunomodulatory therapy

Information from the National Library of Medicine

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


Contacts
Contact: Stephanie Platzer, Dr. +49 3641 ext 9396696 stephanie.platzer@med.uni-jena.de
Contact: Frank M Brunkhorst, Prof. Dr. +49 3641 ext 9323381 Frank.Brunkhorst@med.uni-jena.de

Locations
Germany
Jena University Hospital, Dept. of Cardiac and Thoracic Surgery Recruiting
Jena, Thuringia, Germany, 07747
Contact: Mahmoud Diab, Dr. med.    +49 3641 ext 322978    mahmoud.diab@med.uni-jena.de   
Sponsors and Collaborators
Jena University Hospital
CytoSorbents, Inc
B.R.A.H.M.S. (part of ThermoFisher Scientific)
Fraunhofer Institute for Interfacial Engineering and Biotechnology
German Federal Ministry of Education and Research (BMBF)
Investigators
Study Director: Mahmoud Diab, Dr. Jena University Hospital, Department of Cardiac and Thoracic Surgery

Publications:

Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT03266302     History of Changes
Other Study ID Numbers: ZKSJ0108
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: August 2017
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

Keywords provided by Jena University Hospital:
vasodilatory shock
hemoadsorption
cardiac surgery
cytokines

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection