NCT03945708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.6 years

First QC Date

May 9, 2019

Last Update Submit

September 20, 2021

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

  • Use of vasoactive substances

    Use of norepinephrine in ICU

    48 hours

Secondary Outcomes (3)

  • Milrinone use

    48 hours

  • Chest tube bleeding

    48 hours

  • Blood transfusions

    48 hours

Study Arms (2)

Treatment

EXPERIMENTAL

Addition of whole blood adsorber to CPB circuit

Device: CytoSorb

Control

NO INTERVENTION

Standard treatment

Interventions

CytoSorbDEVICE

Addition of a hemofilter to the cardiopulmonary bypass circuit

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Declines participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Emma Hansson, MD PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 10, 2019

Study Start

May 15, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)