Table 2 Eligibility criteria for INDICATED population
Eligibility criteria consistent with the approved use of DAA in the USA and the EU will define the INDICATED population as follows: | |
|---|---|
1 | Men or women age 18 years or older |
2 | Must have severe sepsis (must meet a, b, and c below) |
a) | Suspected or proven infection |
b) | Systemic inflammatory response syndrome (SIRS) (must meet 2 of 4 criteria) |
i) | Temperature <36°C or >38°C |
ii) | Heart rate >90 beats/minute |
iii) | Respiratory rate >20 breaths/minute or PaC02 <32 mm Hg or on mechanical ventilation |
iv) | White blood cell count <4,000/mm3 or >12,000/mm3 |
a) | At least one organ dysfunction due to sepsis based on definitions of clinically significant organ dysfunction. |
i) | Cardiovascular dysfunction [must meet one of (1), (2), or (3) below]: |
(1) | systolic blood pressure ≤90 mmHg and pH ≤7.3 |
(2) | mean arterial pressure ≤70 mmHg and pH ≤7.3 |
(3) | reported use of a vasopressor alone is sufficient evidence of shock |
i) | Pulmonary dysfunction: PaO2/FiO2 ≤300 mm Hg |
ii) | Central Nervous System dysfunction: Glasgow Coma Score ≤12 |
iii) | Coagulation dysfunction: platelets ≤80,000/mm3 |
iv) | Renal dysfunction: creatinine ≥2.0 mg/dL |
v) | Hepatic dysfunction: bilirubin ≥ 2.0 mg/dL |
1) | High risk of death (one of a, b, or c below) |
a) | APACHE II ≥25 |
b) | SAPS II ≥54 |
c) | Multiple organ dysfunction – two or more clinically significant organ dysfunctions (as defined above), which have occurred within 2 days of each other |
2) | Platelet counts ≥30,000/mm3 |
3) | DAA status known |