INFLACOR - Clinical and Genetic Predictors of Inflammation Related Complications After Heart Surgery

Study Overview
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Brief Summary
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The aim of the study is to evaluate a clinically and economically most effective diagnostic algorithm for prediction of inflammatory response related complications in patients undergoing heart surgery with use of cardiopulmonary bypass.

Detailed Description
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Identified so far predictors of mortality and/or morbidity in patients who undergo heart surgery with cardiopulmonary bypass (CPB), used in previous risk prediction models (EUROSCORE, CABDEAL, Cleveland), will be compared with new candidate variables: anamnestic: recent tooth extractions, chronic inflammatory diseases, specific drug use; biochemical: C-reacting protein, interleukin-6, tumor necrosing factor alpha; genetical: single nucleotide polymorphisms of 10 genes associated with inflammatory response; and clinical from the 1. postoperative day: systemic inflammatory response syndrome, APACHE-III score; against their predictive capability of selected clinical phenotypes of inflammatory response occuring after surgery, beginning from day 2. after surgery.

Official Title
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INFLACOR (INFLA-mmation A-fter C-ardiac O-pe-R-ation) - Use of Selected Genetic Variants, Cytokines, and Physiologic Parameters in the Prognosis of Postoperative Complications in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery

Conditions
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Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Procedure: cardiac surgery with CPB use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (age >=18) given and signed informed consent no previous cardiac surgery with opening the pericardium Exclusion Criteria: previous cardiac surgery with opening the pericardium consent refused or not given

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiac surgery with CPB use<br>Adult patients, who signed the informed consent, intervention: first-time scheduled heart surgery with CPB use. | Procedure: cardiac surgery with CPB use<br>* cardiac surgery with CPB use or ascending aorta surgery performed with use of cardiopulmonary bypass with or without aortic cross clamping.<br>* Other names: open heart surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical phenotypes of inflammatory response: SIRS, acute lung injury/acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, perioperative myocardial infarct/injury, sepsis. |  | between day 2 after operation and hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause inhospital mortality |  | from day 2 after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, cardiopulmonary bypass, acute lung injury, acute respiratory distress syndrome, acute kidney injury, atrial fibrillation, postoperative psychosis, myocardial infarct, sepsis