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Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

NCT02727413 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2019-06-24

No results posted yet for this study

Summary

The study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (CPB) due to either infectious endocarditis or degenerative valvular heart disease. Specific attention will focus on the distinction between mediator release associated with infection and that resulting from CPB. Concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.

Conditions

  • Infective Endocarditis
  • Valvular Heart Disease

Interventions

PROCEDURE

Blood sample collection

Drawing of 10 ml blood at inclusion, at the time of CPB connection, 60 min under CPB, at the time of CPB disconnection, 6, 24 and 48 hours post-surgery

OTHER

Assessment of signs of organ dysfunction

Assessment of signs of organ dysfunction based on medical data prior to surgery, 24 and 48 hours post-surgery, and at the time of ICU discharge

Sponsors & Collaborators

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • Jena University Hospital

    lead OTHER

Principal Investigators

  • Frank M Brunkhorst, MD · Jena University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-02-28
Completion
2017-02-28

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 NCT02727413 on ClinicalTrials.gov