Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase IV Study of Perioperative Steroid's Effects on Death or MI in High-Risk Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass
Brief Summary: SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?


Options:
A: Inclusion Criteria:

* Age \< 1 year at the time of surgery
* Undergoing heart surgery with CPB as part of standard clinical care
* Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

* \< 37 weeks adjusted gestational age at time of surgery
* Any oral or intravenous steroid treatment within two days of surgery
* Any patient receiving any of the following medications within 2 days of surgery:

Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil.

* Infection contraindicating steroid use
* Preoperative mechanical circulatory support or active resuscitation at the time of randomization
* Emergent surgery precluding steroid administration 8-12 hours before surgery
B: Inclusion Criteria:

* Neonates Age \</= 1 month
* Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)
* Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion Criteria:

* Prematurity: \</= 36 weeks post gestational age at time of surgery
* Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery
* Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization
* Suspected infection that would contraindicate steroid use (eg - Herpes)
* Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding)
* Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization
* Inability to begin the pre-operative study drug at least 8 hours prior to surgery
C: 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
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