Inflammatory Mediator Profiles During Heart Valve Replacement Surgery
- Conditions
- Valvular Heart DiseaseInfective Endocarditis
- Interventions
- Procedure: Blood sample collectionOther: Assessment of signs of organ dysfunction
- Registration Number
- NCT02727413
- Lead Sponsor
- Jena University Hospital
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- signed informed consent
- age > 18
- confirmed diagnosis of infective endocarditis or valvular heart disease
- scheduled surgical Intervention with CPB use
- glucocorticoid dosage above Cushing threshold
- severe neutropenia (below 1000/mm3)
- immunosuppression or immunomodulatory therapy
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Infective endocarditis Assessment of signs of organ dysfunction Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with infective endocarditis in accordance with Duke criteria and scheduled for valve surgery Valvular heart disease Blood sample collection Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with valvular heart disease, with no signs of infection, scheduled for valve replacement surgery Infective endocarditis Blood sample collection Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with infective endocarditis in accordance with Duke criteria and scheduled for valve surgery Valvular heart disease Assessment of signs of organ dysfunction Blood sample collection and assessment of signs of organ dysfunction in patients diagnosed with valvular heart disease, with no signs of infection, scheduled for valve replacement surgery
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of C-reactive Protein (CRP) 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of CRP over time
Area under the plasma concentration versus time curve (AUC) of Endothelin 1 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of Endothelin 1 over time
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 10 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of IL 10 over time
Area under the plasma concentration versus time curve (AUC) of Tumor Necrosis Factor (TNF) alpha 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of TNF alpha over time
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 1beta 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of IL 1beta over time
Area under the plasma concentration versus time curve (AUC) of Procalcitonin 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma levels of Procalcitonin over time
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 6 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of IL 6 over time
Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 18 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of IL 18 over time
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of pro-Atrial natriuretic peptide
Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of pro-Adrenomedullin
SOFA Score 24 h before and 24 and 48 h after surgical intervention Changes in SOFA scores after surgery, as compared to pre-surgery baseline
Concomitant medication During and 48 h upon completion of surgical intervention Cumulative doses of applied vasopressors, corticosteroids and prostaglandins
Renal replacement therapy Over 7 days following surgery Use and duration of renal replacement therapy
Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin 24 h before surgery - connection/disconnection of CPB - 24 and 48 h post-surgery Plasma Levels of pro-Arginine vasopressin
In-hospital mortality 30 days after surgery Post-surgical mortality over 30 days
Trial Locations
- Locations (1)
Center for Clinical Studies, Jena University Hospital
🇩🇪Jena, Thuringia, Germany