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Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis

NCT03266302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2025-03-18

No results posted yet for this study

Summary

Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.

Conditions

  • Infective Endocarditis

Interventions

DEVICE

hemoadsorber for removal of cytokines

Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.

Sponsors & Collaborators

  • CytoSorbents, Inc

    collaborator INDUSTRY

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • Fraunhofer Institute for Interfacial Engineering and Biotechnology

    collaborator OTHER

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Mahmoud Diab, Dr. · Jena University Hospital, Department of Cardiac and Thoracic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2020-02-28
Completion
2020-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266302 on ClinicalTrials.gov