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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03945708

  • Recruitment Status

    Recruiting

  • First Posted

    May 10, 2019

  • Last update posted

    October 18, 2019

Study Description

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:Infective Endocarditis
  • Intervention/Treatment: Device: CytoSorb
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020

Arms and interventions

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

Outcome Measures

  • 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

Eligibility Criteria

  • 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

Contacts and Locations

Contacts

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

Locations

Sweden
Sahlgrenska University Hospital
Gothenburg

Sponsors and Collaborators

Emma Hansson

CytoSorbents, Inc

Investigators

Principal Investigator: Emma Hansson, MD PhD Sahlgrenska University Hospital, Sweden

More Information

  • Responsible Party: Emma Hansson
  • ClinicalTrials.gov Identifier: NCT03945708 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Endocarditis, Bacterial Endocarditis