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NCT03945708 Clinical Trial

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

Infective Endocarditis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03945708
Other study ID # 00001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date December 31, 2020

Study information
Verified date September 2021
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Infected endocarditis patients undergoing heart valve surgery. 2. Age over 18 years. Exclusion Criteria: 1 Declines participation

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CytoSorb
Addition of a hemofilter to the cardiopulmonary bypass circuit

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (2)
Lead Sponsor Collaborator
Emma Hansson CytoSorbents, Inc

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Use of vasoactive substances Use of norepinephrine in ICU 48 hours
Secondary Milrinone use Amount of milrinone used 24 and 48 hours postoperatively 48 hours
Secondary Chest tube bleeding Chest tube output in ml 48 hours
Secondary Blood transfusions Transfusion of red blood cells, plasma and platelets 48 hours
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