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

    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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