Inflammatory Mediator Profiles During Heart Valve Replacement Surgery

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02727413
Study type	Observational
Source	Jena University Hospital
Contact
Status	Completed
Phase
Start date	June 2016
Completion date	February 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Completed	`NCT02241109` - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity	N/A
Completed	`NCT03799133` - Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery	N/A
Completed	`NCT01676727` - ADVANCE Direct Aortic Study
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT00721136` - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation	N/A
Recruiting	`NCT05044338` - Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease
Recruiting	`NCT05014750` - Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
Recruiting	`NCT05015829` - Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis
Recruiting	`NCT05078619` - Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation	N/A
Recruiting	`NCT06307262` - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed	`NCT01624870` - CoreValve Advance-II Study: Prospective International Post-market Study
Completed	`NCT05708690` - Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery	Phase 4
Recruiting	`NCT03797820` - Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly（Mrs AVS）
Recruiting	`NCT06077721` - Milrinone on Right Ventricular Strain in Cardiac Surgery
Not yet recruiting	`NCT04632914` - Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery	N/A
Completed	`NCT01477151` - Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery	Phase 4
Terminated	`NCT03590730` - Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Recruiting	`NCT06204783` - Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)
Enrolling by invitation	`NCT05775354` - Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Inflammatory Mediator Profiles During Heart Valve Replacement Surgery — Remove-Pilot

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms