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To be considered for
a drotecogin alfa therapy, the patient should meet all three of the following
criteria:
1. A known or suspected
site of infection indicated by one or more of the following:
•Purulent sputum
or respiratory sample
A chest radiograph
with new infiltrates not explained by a noninfectious process
•Spillage of bowel
contents noted during an operation
•Radiographic or
physical examination evidence of an infected collection
•White blood cells
in a normally sterile body fluid
•Positive blood
culture
•Evidence of infected
mechanical hardware by physical or radiologic examination
2. Evidence of systemic
inflammatory syndrome as indicated by at least three of the following:
•Hypothermia or
fever: core body temperature of < 36°C (96.8°F) or > 38°C (100.4°F)
•Tachypnea: >
20 breaths/min or on mechanical ventilation for an acute process
•Heart rate: >
90 bpm
except:
1. the patient
has a pacemaker, or
2. the patient
is on pharmacological therapy for pre-existing tachycardia
White Blood Cell
Count: > 12,000 or < 4,000 cells/mm3 or > 10% bands on differential
3. Sepsis-induced
organ failure criteria
(Note: Organ failure may not be explained by another non-sepsis illness
and cannot be greater than 48 hours in duration.)
•Severe sepsis (criteria
1 and 2) with an APACHE II score > 25
AND
•Cardiovascular
System Dysfunction
°Evidence of
septic shock, defined as mean arterial blood pressure of < 60mmHg,
or systolic arterial pressure of < 90 mmHg or the need for vasopressors
to maintain these blood pressures in the face of adequate intravascular
volume (central venous pressure of > 8 mmHg or pulmonary artery
occlusion pressure of > 12 mmHg), or after an adequate fluid
challenge (12 ml/kg) has been given.
OR
In the absence of
septic shock, the patient should have two or more of the following organ
failures:
•Respiratory System
Dysfunction
-PaO2/FiO2 ratio < 200
•Renal Dysfunction
-Urine output < 0.5 ml/kg/hr for 1 hour in the face of adequate intravascular
volume or after an adequate fluid challenge has been given
•Hematologic Dysfunction
-Thrombocytopenia < 80,000 platelets/mm3 or a 50% drop
in the last 3 days, or an INR > 1.2 not explained by liver disease
or concomitant warfarin usage
•Unexplained Metabolic
Acidosis
-pH < 7.30 with an elevated plasma lactate level that is > 1.5
times the upper limit of normal
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