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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients that develop SIRS | Immunophenotyping of patients that develop SIRS after heart surgery |
| |
| Patients that develop no SIRS | Immunophenotyping of patients that develop no SIRS after heart surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunophenotyping | Other | Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing open heart surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Bode, MD | Contact | +4922828714119 | christian.bode@ukb.uni-bonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Eicke Latz, MD, PhD | Institute of Innate Immunity | Study Chair |
| Christian Bode, MD | Department of Anesthesia and Critical Care Medicine | Study Chair |
| Folkert M Steinhagen, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bonn | Recruiting | Bonn | 53127 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D016130 | Immunophenotyping |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum and Leukocytes
| 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 |
| Department of Anesthesia and Critical Care Medicine |
| Principal Investigator |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |