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

NCT ID: NCT03945708

Last Updated: 2021-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Infective Endocarditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

Addition of whole blood adsorber to CPB circuit

Group Type EXPERIMENTAL

CytoSorb

Intervention Type DEVICE

Addition of a hemofilter to the cardiopulmonary bypass circuit

Control

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CytoSorb

Addition of a hemofilter to the cardiopulmonary bypass circuit

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1 Declines participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CytoSorbents, Inc

INDUSTRY

Sponsor Role collaborator

Emma Hansson

OTHER

Sponsor Role lead

Responsible Party

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Emma Hansson

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Emma Hansson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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00001

Identifier Type: -

Identifier Source: org_study_id

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