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

September 20, 2021 updated by: Emma Hansson

Does Whole Blood Adsorber During CPB Reduce the Amount of Vasoactive Drugs Postoperatively in Endocarditis Patients Undergoing Valve Surgery? -a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1 Declines participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment
Experimental: Treatment
Addition of whole blood adsorber to CPB circuit
Device: CytoSorb
Addition of a hemofilter to the cardiopulmonary bypass circuit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of vasoactive substances
Time Frame: 48 hours
Use of norepinephrine in ICU
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Milrinone use
Time Frame: 48 hours
Amount of milrinone used 24 and 48 hours postoperatively
48 hours
Chest tube bleeding
Time Frame: 48 hours
Chest tube output in ml
48 hours
Blood transfusions
Time Frame: 48 hours
Transfusion of red blood cells, plasma and platelets
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emma Hansson

Collaborators

CytoSorbents, Inc

Investigators

  • Principal Investigator: Emma Hansson, MD PhD, Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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