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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 : Completed
First Posted : August 30, 2017
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
CytoSorbents, Inc
Thermo Fisher Scientific
Fraunhofer Institute for Interfacial Engineering and Biotechnology
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Jena University Hospital

Tracking Information
First Submitted Date  ICMJE August 28, 2017
First Posted Date  ICMJE August 30, 2017
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE January 17, 2018
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
SOFA Score [ Time Frame: 24 hours before until day 9 post-surgery ]
We will test if mean SOFA scores are different for the experimental and control group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Infective Endocarditis
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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)
    Intervention: Device: hemoadsorber for removal of cytokines
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2020)
288
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2017)
250
Actual Study Completion Date  ICMJE February 28, 2020
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03266302
Other Study ID Numbers  ICMJE ZKSJ0108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jena University Hospital
Study Sponsor  ICMJE Jena University Hospital
Collaborators  ICMJE
  • CytoSorbents, Inc
  • Thermo Fisher Scientific
  • Fraunhofer Institute for Interfacial Engineering and Biotechnology
  • German Federal Ministry of Education and Research
Investigators  ICMJE
Study Director: Mahmoud Diab, Dr. Jena University Hospital, Department of Cardiac and Thoracic Surgery
PRS Account Jena University Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP