Immunophenotyping of Patients With Postoperative SIRS

Study Overview
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Brief Summary
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The purpose of this study is to develop an immune-phenotype based prediction of postoperative SIRS in patients undergoing open heart surgery.

Detailed Description
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The study will have a pre-, intra and postoperative phase in which several demographic and clinical variables will be assessed. The samples for the immunophenotypic analysis will be drawn directly after induction of anesthesia and at various time points after end of surgery. The diagnosis of SIRS will be made during routine clinical visits on the first seven postoperative days using the Sepsis-related Organ Failure Assessment score (SOFA-score). The patients will be followed up for 30 days.

Official Title
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Immunophenotyping of Patients Undergoing Open Heart Surgery to Assess Their Susceptibility of Developing a Systemic Inflammatory Response Syndrome (SIRS)

Conditions
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Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Other: Immunophenotyping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Informed consent of the patient Patient undergoing a open heart surgery using a cardiopulmonary bypass Exclusion Criteria: Age < 18 years Missing informed consent Renal failure Liver failure Neurodegenerative disease Malignancies Immune therapy

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 |
| --- | --- |
| Patients that develop SIRS<br>Immunophenotyping of patients that develop SIRS after heart surgery | Other: Immunophenotyping<br>* Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach<br>|
| Patients that develop no SIRS<br>Immunophenotyping of patients that develop no SIRS after heart surgery | Other: Immunophenotyping<br>* Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with SIRS as assessed by SOFA-Score | The study investigates the relationship between the intra-individual inflammatory patterns in patients with uncomplicated (no SIRS) and complicated postoperative courses (SIRS) after open heart surgery. The diagnosis of SIRS will be made by using the Sepsis-related Organ Failure Assessment score (SOFA-score). Patients with an increase in SOFA-score >3 are considered to have SIRS. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with need for renal replacement therapy because of acute kidney failure (AKIN classification) |  | 30 days | 
| Number of participants with infection as assessed by microbiological, serological and radiological examination |  | 30 days | 
| Number of participants with postoperative delir as assessed by CAM-ICU |  | 30 days | 
| Number of participants with myocardial injury as assessed by troponine and CK-MB serum levels |  | 30 days | 
| Number of participants with new atrial fibrillation as assessed by ECG |  | 30 days | 
| Length of stay in ICU |  | 30 days | 
| Length of stay in hospital |  | 30 days | 
| In-hospital mortality |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunophenotyping, Perioperative Care, Innate Immunity, Cardiac Surgical Procedures