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出境医 / 临床实验 / Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?

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

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 Intervention/treatment Phase
Infective Endocarditis Device: CytoSorb Not Applicable

Study Design
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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
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
No Intervention: Control
Standard treatment
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
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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

Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019) 		Use of vasoactive substances [ Time Frame: 48 hours ]
Use of norepinephrine in ICU
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Milrinone use [ Time Frame: 48 hours ]
    Amount of milrinone used 24 and 48 hours postoperatively
  • Chest tube bleeding [ Time Frame: 48 hours ]
    Chest tube output in ml
  • Blood transfusions [ Time Frame: 48 hours ]
    Transfusion of red blood cells, plasma and platelets
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 Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?
Official Title  ICMJE Does Whole Blood Adsorber During CPB Reduce the Amount of Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? -a Randomized Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Infective Endocarditis
Intervention  ICMJE Device: CytoSorb
Addition of a hemofilter to the cardiopulmonary bypass circuit
Study Arms  ICMJE
  • Experimental: Treatment
    Addition of whole blood adsorber to CPB circuit
    Intervention: Device: CytoSorb
  • No Intervention: Control
    Standard treatment
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2019) 		20
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		40
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

1 Declines participation
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: Emma Hansson, MD PhD +46313427513 emma.hansson@vgregion.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945708
Other Study ID Numbers  ICMJE 00001
Has Data Monitoring Committee No
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 Emma Hansson, Sahlgrenska University Hospital, Sweden
Study Sponsor  ICMJE Emma Hansson
Collaborators  ICMJE CytoSorbents, Inc
Investigators  ICMJE
Principal Investigator: Emma Hansson, MD PhD Sahlgrenska University Hospital, Sweden
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date October 2019

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

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