Figure 1. The Cleveland Clinic Foundation Guidelines for the Use of Drotrecogin alfa

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

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


•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.


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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