Clinical Impact of Cytokine in Cardiac Surgery

Study Overview
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Brief Summary
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Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients. The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.

Detailed Description
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Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.

Official Title
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Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization

Conditions
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Coronary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Elective myocardial revascularization Exclusion Criteria: Emergency procedures Declined informed consent Body mass index < 18 Age < 18 years Pregnant women Receiving chemotherapy Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia Receiving antileukocyte drugs Receiving TNF-α Blockers Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen) CRP > 5 mg/dl

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPB + Cytosorb<br>On pump myocardial revascularization with the use of the cytokine adsorbing circuit (Cytosorb) | |
| CPB / Control<br>Controll group; on pump myocardial revascularization | |
| OPCAB / Control<br>Controll Group; off-pump myocardial revascularization | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the inflammatory response | Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP | Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU and hospital stay | Length of ICU and hospital stay | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Length of ventilation | Length of ventilation (hours) | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Length of catecholamine therapy | Length of catecholamine therapy | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| kidney injury | kidney injury defined as an increase in SCr by ≥1.0 mg/dl (≥26.5 μmol/l) after surgery ; or Increase in SCr to ≥1.5 times baseline, or Urine volume < 0.5 ml/kg/h for 6 hours. | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| MACCE (mortality; myocardial infarction; cerebrovascular accident) | Mortality measured as any kind of death and myocardial death Myocardial Infarction measured with ECG; CK-MB, cTnT Cerebrovascular accident verified with abnormal cerebral CT scan | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial revascularization, Cytosorb, Inflammatory response, Cardiopulmonary bypass