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Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945708
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
CytoSorbents, Inc
Information provided by (Responsible Party):
Emma Hansson, Sahlgrenska University Hospital, Sweden

Brief Summary:
The study aims to investigate the effect of addition of an adsorber during cardio pulmonary bypassin patients with infective endocarditis undergoing valve surgery, and if it will decrease the use of vasoactive drugs postoperatively.

Condition or disease Intervention/treatment Phase
Infective Endocarditis Device: CytoSorb Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does Whole Blood Adsorber During CPB Reduce the Amount of Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? -a Randomized Controlled Study
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arm Intervention/treatment
Experimental: Treatment
Addition of whole blood adsorber to CPB circuit
Device: CytoSorb
Addition of a hemofilter to the cardiopulmonary bypass circuit

No Intervention: Control
Standard treatment



Primary Outcome Measures :
  1. Use of vasoactive substances [ Time Frame: 48 hours ]
    Use of norepinephrine in ICU


Secondary Outcome Measures :
  1. Milrinone use [ Time Frame: 48 hours ]
    Amount of milrinone used 24 and 48 hours postoperatively

  2. Chest tube bleeding [ Time Frame: 48 hours ]
    Chest tube output in ml

  3. Blood transfusions [ Time Frame: 48 hours ]
    Transfusion of red blood cells, plasma and platelets



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Infected endocarditis patients undergoing heart valve surgery.
  2. Age over 18 years.

Exclusion Criteria:

1 Declines participation


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): NCT03945708


Contacts
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Contact: Emma Hansson, MD PhD +46313427513 emma.hansson@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Anna Holmén       anna.holmen@vgregion.se   
Sponsors and Collaborators
Emma Hansson
CytoSorbents, Inc
Investigators
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Principal Investigator: Emma Hansson, MD PhD Sahlgrenska University Hospital, Sweden

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Responsible Party: Emma Hansson, Principal Investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03945708    
Other Study ID Numbers: 00001
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection