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:

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:

* Patients scheduled for a non-cardiac surgical procedure of high or intermediate cardiac risk are eligible if they have documented coronary artery disease (CAD) or are at high risk of CAD.

Exclusion Criteria:

* Ongoing medication with sulfonylurea derivatives (unless stopped ≥ 2 days before surgery) or theophylline
* Emergency surgery
* Unstable angina pectoris
* Preoperative hemodynamic instability
* Severe hepatic disease
* Renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second \[FEV1\] \< 1 litre)
* Absence of written patient consent
C: Inclusion Criteria:

* All types of cardiac surgery in which cardiopulmonary bypass is used

Exclusion Criteria:

* Age under 18 years
* Life-expectancy \< 6 months
* Emergency operations
* Re-operations within the same admission
D: Inclusion Criteria:

* is 65 years of age or older at admission;
* has surgical treatment of a traumatic hip fracture;
* has participating surgeon;
* has Mini-Mental Status Exam score of 15 or higher;
* able to read/write/speak/hear/understand English;
* gives informed consent;
* receives spinal anesthesia

Exclusion Criteria:

* receives general anesthesia;
* does not write/write/speak/hear/understand English;
* has severe chronic obstructive pulmonary disease (COPD);
* has severe congestive heart failure (CHF);
* has Mini-Mental Status Exam score less than 15;
* declines to give informed consent;
* age less than 65 years at admission;
* attending surgeon does not participate in study

Answer: A