Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III of Recombinant Human Activated Protein C and Low Dose of Hydrocortisone and Fludrocortisone in Adult Septic Shock
Brief Summary: This study aims at comparing the efficacy and safety of recombinant human activated protein C to that of low dose of corticosteroids and at investigating the interaction between these drugs in the management of septic shock


Options:
A: Inclusion Criteria:

* adult patients
* who underwent cardiac surgery
* have Risk of Acute Renal Failure (R of RIFLE score)

Exclusion Criteria:

* glaucoma
* already on renal replacement therapy
* study drug in the past 30 days
* inclusion in other protocols
B: Inclusion Criteria:

* Patients ≥ 60 years of age
* Undergoing CABG with/without valve (aortic and/or mitral) procedure requiring bypass

Exclusion Criteria:

* Pre-operative Left Ventricular Ejection Fraction (LVEF) \< 30%
* Emergent or urgent procedures, aortic surgery
* Pre-existing cognitive impairment (defined based on a short screening assessment), Parkinson's disease, Alzheimer's disease, recent seizures (\<3 months)
* Prophylactic medications for cognitive decline
* Serum creatinine \> 2 mg/dl
* Liver dysfunction (liver enzymes \> 4x the baseline, since patients will have a baseline liver function tests), history and exam suggestive of jaundice
* Known history of alcohol or drug abuse (\>10 drinks per week)
* Hypersensitivity to any of the study drug and percutaneous procedures
* Non-English speaking
C: Inclusion Criteria:

* hospitalized in intensive care unit for less than 7 days
* septic shock for less than 24 hours
* at least one proven site of infection
* at least 2 organ dysfunction as defined by a SOFA score =or\> to 3 for at least 6 consecutive hours
* need for vasopressor (dopamine =or\>15µg/kg/min or epinephrine/norepinephrine at =or\>0,25 µg/kg/min for at least 6 consecutive hours, to maintain systolic arterial pressure at 90 mmHg or more OR mean arterial pressure at 6( mmHg or more
* informed consent

Exclusion Criteria:

* pregnancy or breath feeding
* decision not to resuscitate
* underlying disease with an estimated life expectancy of less than 1 month
* formal indication for corticosteroids
* recent surgery (ie within the past 72 hours) or a surgery at high risk of bleeding
* gastro-intestinal bleeding within the past 6 weeks
* chronic liver disease (Child C)
* recent trauma (ie within the past 72 hours)
* intracranial process
* history of stroke, CNS bleeding or traumatic brain injury within the past 3 months
* platelet counts of less than 30000 per cubic millimeter
* formal indication for curative anticoagulant; prophylactic use of heparin is allowed
* any condition of high risk of bleeding as per patient's primary physicians
* hypersensitivity of activated drotrecogin alpha or any other component of the drug
* no affiliation to a social security

Amendments to eligibility criteria were:

On 27/03/2008: Changes in following exclusion criteria :

* "surgical procedure in the past 7 days" was changed for "surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h".
* "chronic liver disease" was clarified as "chronic liver disease with Child score C".
* "severe thrombopenia" was clarified "as severe thrombopenia (\<30,000/mm3, before transfusion).

On 25/08/2009: The exclusion criteria: surgical procedure within 72 hours, or any surgery associated with high risk of bleeding, or a planned surgery within 24 h" was changed for "surgical procedure within 12 hours, or any surgery associated with high risk of bleeding

On 11/06/2010: the inclusion criteria: admitted to the ICU for \< 7 days was removed; and a new exclusion criteria was added: "patients who had a previous episode of sepsis during the same hospital stay

On 18/04/2012: following the withdrawal of DAA from the market: the following exclusion criteria (only related to DAA) were removed :

1. any surgery in the past 12 hours, or any surgery associated with high risk of bleeding;
2. chronic liver disease with a Child score C;
3. recent trauma;
4. any intracranial mass, or stroke or head injury in the past 3 months;
5. severe thrombocytopenia (\< 30.000 /mm3, before platelet transfusion);
6. formal indication for anticoagulation, or any other condition associated with increased risk of bleeding, as appreciated by the patient's physician.
D: Inclusion Criteria:

* Male or female patients undergoing primary or re-operative Coronary Artery Bypass Graft (CABG) and/or valvular surgery or ascending aorta surgery that requires Cardio-pulmonary bypass (CPB) who are at high risk for neurologic complications (stroke or encephalopathy) as determined by a Johns Hopkins risk score of \>0.02

Exclusion Criteria:

* Contraindication to MRI imaging (e.g., permanent pacemaker, cerebral arterial vascular clips)
* Liver function test before surgery more than twice the upper limit of institutional normal
* Pre-existing renal dysfunction defined as an estimated glomerular filtration rate of ≤60 mL/min, or current renal dialysis
* Emergency surgery
* Inability to attend outpatient visits
* Visual impairment or inability to speak and read English. The patient will be excluded from further study if an adequate temporal window for Transcranial Doppler (TCD) monitoring can not be identified before surgery.

Answer: C