Inflammatory Mediator Profiles During Heart Valve Replacement Surgery (Remove-Pilot)

Jena University Hospital

Status: Completed

Conditions: Valvular Heart Disease; Infective Endocarditis

Treatments: Procedure: Blood sample collection; Other: Assessment of signs of organ dysfunction

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02727413

ZKS0071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Infective endocarditis

Description:

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

Treatment:

Procedure: Blood sample collection

Other: Assessment of signs of organ dysfunction

Valvular heart disease

Description:

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

Treatment:

Procedure: Blood sample collection

Other: Assessment of signs of organ dysfunction