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Completed

NCT Number: NCT02727413

Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

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.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases Heart Valve Diseases Valvular Heart Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Clinical Studies, Jena University Hospital

Jena, Thuringia, 07747, Germany

About this study

Exaggerated release of inflammatory mediators and endogenous vasoactive substances resulting from the coincident infection and surgical stress plays a role in post-operative organ failure and altered immune defense, thus contributing to unfavorable post-operative outcome.

Cardiopulmonary bypass (CPB) itself, even in the absence of IE, has been shown to modify cytokine and vasoactive mediator release and may cause organ failure. Tracing of release profiles of inflammatory cytokines and vasoactive mediators and their correlation with postoperative organ dysfunction in cardiac surgery for IE or non-IE patients aims at the assessment of the prognostic validity of these biomarkers and the evaluation of measures for their pro-active clearance during the surgical intervention.

Induction of inflammatory mediators and their temporal release profile may vary depending on the involved pathogens, which cannot be always identified by conventional techniques (blood culture). Since it is conceivable that identification of the involved pathogen could explain differences in cytokine secretory patterns in IE, use of advanced molecular technologies (NGS) will support the clarification of such relations. Analysis of transcripts encoding inflammatory and vasoactive mediators in blood cells will enable the surveillance of temporal oscillations in their profiles during the observation time frame. Transcriptome analysis of identified putative pathogens can also disclose features of antibiotic resistance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent
  • age > 18
  • confirmed diagnosis of infective endocarditis or valvular heart disease
  • scheduled surgical Intervention with CPB use

Exclusion criteria

  • glucocorticoid dosage above Cushing threshold
  • severe neutropenia (below 1000/mm3)
  • immunosuppression or immunomodulatory therapy
  • pregnancy

Treatment and study plan

blood sample collection

Procedure

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

Assessment of signs of organ dysfunction

Other

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

Other names: SOFA score

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of Procalcitonin

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma levels of Procalcitonin over time

  2. Area under the plasma concentration versus time curve (AUC) of C-reactive Protein (CRP)

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of CRP over time

  3. Area under the plasma concentration versus time curve (AUC) of Endothelin 1

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of Endothelin 1 over time

  4. Area under the plasma concentration versus time curve (AUC) of Tumor Necrosis Factor (TNF) alpha

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of TNF alpha over time

  5. Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 1beta

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of IL 1beta over time

  6. Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 6

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of IL 6 over time

  7. Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 10

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of IL 10 over time

  8. Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 18

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of IL 18 over time

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of pro-Adrenomedullin

  2. Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of pro-Arginine vasopressin

  3. Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide

    Time frame: 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery

    Plasma Levels of pro-Atrial natriuretic peptide

  4. SOFA Score

    Time frame: 24 h before and 24 and 48 h after surgical intervention

    Changes in SOFA scores after surgery, as compared to pre-surgery baseline

  5. Renal replacement therapy

    Time frame: Over 7 days following surgery

    Use and duration of renal replacement therapy

  6. Concomitant medication

    Time frame: During and 48 h upon completion of surgical intervention

    Cumulative doses of applied vasopressors, corticosteroids and prostaglandins

  7. In-hospital mortality

    Time frame: 30 days after surgery

    Post-surgical mortality over 30 days

Other outcomes

  1. Pathogen genotyping

    Time frame: Before and during intervention at the heart valve

    Identification of circulating pathogens

  2. Resistance transcripts

    Time frame: During intervention at the heart valve

    Abundance of bacterial transcripts encoding antibiotic resistance in blood

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • Thermo Fisher Scientific, Inc

Registry information

Official study title

Inflammatory and Vasoactive Mediator Profiles and Pathogen Characterization During Heart Valve Replacement Surgery

Acronym: Remove-Pilot

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2016
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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