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ADULTS
Restricted to Surgical and Pulmonary Critical Care Attending Physicians
(listed below)
Drug to be administered to ICU patients or patients transferring to ICU
Dose: 24 mcg/kg/hr x 96 hours
Patients must meet BOTH criteria I and II
I. The decision to administer
drotrecogin alfa must
be made and carried out within 24 hours of
ACUTE ORGAN DYSFUNCTION DUE TO SEPSIS OR SIRS
This therapy should be reserved for
patients with severe sepsis with a high risk of mortality as determined
by
evidence of 2 or more ORGAN DYSFUNCTION criteria
and/or APACHE II score > 25 (see worksheet in Pharmacy References)
|
Yes |
No |
Criteria |
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|
Organ Dysfunction |
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1. CARDIOVASCULAR |
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An arterial systolic blood
pressure of < 90 mm Hg |
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A mean arterial pressure
(MAP) < 70 mm Hg for at least 1 hour despite adequate
fluid resuscitation. |
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Inadequate intravascular
volume status and/or the need for vasopressors (dopamine
5 mcg/kg/min, to maintain systolic blood
pressure > 90 mm HG or MAP >
70 mm HG. |
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2. RENAL |
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Urine output < 0.5 mL/kg/hr
for one hour, despite adequate fluid resuscitation. |
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3. RESPIRATORY |
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PaO2/FiO2 < 250 (If
patient has pneumonia, the patient must have a PaO2/FiO2
<200). As must be judged by the
attending physician, respiratory failure must be
sepsis- or SIRS-related. |
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4. HEMATOLOGY |
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Platelet count of < 80,000 mm3 or a 50% decrease in
the platelet count from the highest
value recorded over the last 3 days. |
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5. METABOLIC
ACIDOSIS |
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pH < 7.3 or base deficit > 5 mEq/L in
conjunction with a plasma lactate level > 1.5 times
the upper limit of normal. |
II. Patient Must Have
Suspected OR Proven Infection:
|
Yes |
No |
Criterion |
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|
Known or suspected
infection? (e.g., positive blood culture, perforated viscus,
white blood cells in normally sterile body fluid, evidence of
pneumonia) |
If
no confirmed infection, patient must have any 3 of the 4 following SIRS
criteria:
|
Yes |
No |
SIRS Criteria |
| |
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Fever > 38o
C (100.4oF) or hypothermia < 36oC (96.8oF) |
| |
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Heart rate > 90
beats/minute |
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Respiratory rate >
20 breaths per minute or a PaCO2 < 32 mm Hg or
mechanical ventilation for an acute process. |
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White blood cell (WBC)
count of > 12,000/mm3 or < 4,000/mm3
or > 10% immature neutrophils. |
Treatment
of patients surrounding surgical procedures:
1. Percutaneous procedures:
The
manufacturer recommends to stop infusion 2 hours before the
procedure
and resume 1 hour
after the procedure.
2. Major surgery:
Manufacturer
recommends to stop infusion 2 hours before surgery and resume 12 hours
after
surgery in the
absence of bleeding complications. The decision when to restart
following surgery should be made
by the surgeon and
critical care attending after consideration of risk and benefit.
Surgical and
Pulmonary Critical Care Attending Physicians
| Paul Kearney |
Rolando
Berger |
| Bernard
Boulanger |
Scott
Morehead |
| Andrew
Bernard |
Ketan Buch |
| Phillip
Chang |
Eric
Bensadoun |
| Michael Rie |
|
III. Contraindications:
[ ]
Active internal
bleeding
[ ]
Intracranial
neoplasm or evidence of cerebral herniation or mass lesion
[ ]
Recent hemorrhagic stroke (within 3 months)
[ ]
Recent intracranial or intraspinal surgery; severe head
trauma (within 2 months)
[ ]
Presence of an epidural catheter
[ ]
Trauma with an increased risk of life-threatening bleeding
[ ]
Known hypersensitivity to drotrecogin alfa (activated) or
any of its components
IV:
Precautions
[ ] Patients with single organ dysfunction and surgery within
30 days prior to treatment
[ ]
Concurrent
therapeutic anticoagulation (prophylaxis is acceptable)
[ ]
Platelet count
less than 30,000 x 10(6)/L
[ ]
Prothrombin time-INR
greater than 3
[ ]
Recent
gastrointestinal bleeding (within 6 weeks)
[ ]
Recent
administration of thrombolytic therapy (within 3 days)
[ ]
Recent
administration of oral anticoagulants or glucoprotein IIb/IIIa
inhibitors (within 7 days)
[ ]
Recent
administration of aspirin greater than 650 mg per day or other platelet
inhibitors (within 7 days)
[ ]
Recent ischemic
stroke (within 3 months)
[ ]
Intracranial
arteriovenous malformation or aneurysm
[ ]
Known bleeding
diathesis
[ ]
Chronic severe
hepatic disease
[ ]
Pregnancy
[ ]
Any other
condition in which bleeding is a significant hazard or would be
especially difficult to manage because of its location
[ ] Moribund
state – patient not expected to survive because of an uncorrectable
medical condition
[ ] Pediatric
patients – Limited data exists in patients < 18 years and should be used
with caution. Physicians authorized to
prescribe for this group includes:
Cheri Landers
Horacio Zaglul
M. Dawn Turner
Philip Bernard
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