Back to resultsDoes Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?
Primary Purpose
Infective Endocarditis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CytoSorb
Sponsored by
About this trial
This is an interventional supportive care trial for Infective Endocarditis
Eligibility Criteria
Inclusion Criteria:
- Infected endocarditis patients undergoing heart valve surgery.
- Age over 18 years.
Exclusion Criteria:
1 Declines participation
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Addition of whole blood adsorber to CPB circuit
Standard treatment
Outcomes
Primary Outcome Measures
Use of vasoactive substances
Use of norepinephrine in ICU
Secondary Outcome Measures
Milrinone use
Amount of milrinone used 24 and 48 hours postoperatively
Chest tube bleeding
Chest tube output in ml
Blood transfusions
Transfusion of red blood cells, plasma and platelets
Full Information
NCT ID
NCT03945708
First Posted
May 9, 2019
Last Updated
September 20, 2021
Sponsor
Emma Hansson
Collaborators
CytoSorbents, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03945708
Brief Title
Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emma Hansson
Collaborators
CytoSorbents, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Addition of whole blood adsorber to CPB circuit
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment
Intervention Type
Device
Intervention Name(s)
CytoSorb
Intervention Description
Addition of a hemofilter to the cardiopulmonary bypass circuit
Primary Outcome Measure Information:
Title
Use of vasoactive substances
Description
Use of norepinephrine in ICU
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Milrinone use
Description
Amount of milrinone used 24 and 48 hours postoperatively
Time Frame
48 hours
Title
Chest tube bleeding
Description
Chest tube output in ml
Time Frame
48 hours
Title
Blood transfusions
Description
Transfusion of red blood cells, plasma and platelets
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infected endocarditis patients undergoing heart valve surgery.
Age over 18 years.
Exclusion Criteria:
1 Declines participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Hansson, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Whole Blood Adsorber During CPB Reduce Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery?
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