Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter
Brief Summary: Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course.

Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.


Options:
A: Inclusion Criteria:

1. Age greater than 18 years
2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
3. Must have a EuroSCORE ≥ 6
4. Provide written informed consent

NOTE: For participating sites in India, China and Hong Kong, the following eligibility criteria will be applied:

1. Age greater than 18 years
2. Require CPB for any cardiac surgical procedure (such as CABG, Valve, Aorta, or combined procedures)
3. Must have at least one of the following:

   1. EuroSCORE greater than or equal to 4 and undergoing valvular surgery
   2. EuroSCORE greater than or equal to 6 and undergoing any other cardiac surgery procedure (i.e. CABG, Aorta)
4. Provide written informed consent

Exclusion Criteria:

1. Use of systemic corticosteroids
2. History of bacterial or fungal infection in last 30 days
3. Allergy/intolerance to corticosteroids
4. Will receive Aprotinin
5. Previous participation in study
B: Inclusion Criteria:

* Valve replacement under cardiopulmonary bypass

Exclusion Criteria:

* Cardiopulmonary bypass time over 120 minutes
* Hyperlipidemia
* Diabetes mellitus
* Autoimmune diseases
C: Inclusion Criteria:

* elective cardiac surgical intervention with an expected CBP duration \>120 minutes

Exclusion Criteria:

* Emergency procedures
* Heart transplantation
* Elective left ventricular assist device (LVAD) implantation
* Pulmonary thromendarterectomy
* Declined informed consent
* Serum creatinine \> 2mg/dl
* Body mass index \< 18
* Age \< 18 years
* Pregnant woman
* Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
* Receiving antileukocyte drugs
* Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
* CRP \> 2mg/dl
* History of Stroke
* Bilirubin \>2mg/dl
D: Inclusion Criteria:

* Participants undergoing cardiac surgery: coronary artery bypass grafting, heart valve surgery or a combined procedure,
* Procedure must be elective

Exclusion Criteria:

* Symptomatic cerebrovascular disease,
* Cerebrovascular incident in last 3 years,
* Neurodegenerative disease,
* Psychiatric disease,
* Visual, hearing or motor impairment interfering with cognitive testing,
* Carotid artery stenosis ( ≥50%),
* Myocardial infarction within last 3 months,
* Left ventricular ejection fraction of ≤35%,
* Previous cardiac or carotid surgery,
* Uncontrolled systemic hypertension (blood pressure≥180/110 mmHg),
* Corticosteroid-dependent asthma,
* Chronic obstructive pulmonary disease (COPD),
* Malignancy, liver disease (aspartate transaminase (AST), alanine transaminase (ALT) or bilirubin ˃1.5x above reference range),
* Kidney disease (serum creatinine ˃1.7 mg/dl or blood urea nitrogen ˃50 mg/dL),
* Uncontrolled diabetes mellitus (postprandial glucose ˃200 mg/dL or hemoglobin A1c ˃9%),
* Endocrine and metabolic diseases, requiring steroid treatment longer than 7 days in the past year,
* Alcohol or controlled substance abuse,
* Individuals without primary school education,
* Preoperative C reactive protein ˃0.5 mg/dL,
* Preoperative white blood cell count \<3 x109/L or ˃11 x109/L,
* Preoperative Mini mental score \<26 points,
* Preoperative Beck's depression inventory score ˃ 19 points,
* Intraoperative plan change (conversion from "off-pump" to "on-pump" and vice versa),
* Need for deep hypothermic circulatory arrest,
* Additional corticosteroid treatment throughout the study period.

Answer: C