Table 2 Summary of inclusion and exclusion criteria
Inclusion criteria | Exclusion criteria |
|---|---|
Subjects who meet the following criteria (and have a signed informed consent) will be allowed into the study: | 1. Inability to obtain an informed consent from the subject, family member or an authorized surrogate |
1. Age ≥18 years of age | 2. Lack of commitment for full medical support |
2. Hypotension requiring vasopressor support: Requirement for at least one of the vasopressors listed below, at the dose shown below, for at least 2 continuous hours and no more than 30 hours | 3. Inability to achieve or maintain a minimum mean arterial pressure of ≥65 mmHg despite vasopressor therapy and fluid resuscitation |
a. Norepinephrine >0.05 μg/kg/minute | 4. Subject has end-stage renal disease and requires chronic dialysis |
b. Dopamine >10 μg/kg/minute | 5. There is clinical support for non-septic shock such as |
c. Phenylephrine >0.4 μg/kg/minute | a. Acute pulmonary embolus |
d. Epinephrine >0.05 μg/kg/minute | b. Transfusion reaction |
e. Vasopressin >0.03 units/minute | c. Severe congestive heart failure (for example, New York Heart Association Class IV, ejection fraction <35%) |
f. Vasopressin (any dose) in combination with another vasopressor listed above | 6. Subject has had chest compressions as part of cardiopulmonary resuscitation this hospitalization without immediate return to communicative state |
3. The subject must have received intravenous fluid resuscitation of a minimum 30 mL/kg administered within 24 hours of eligibility | |
4. Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration | 7. Subject has had an acute myocardial infarction within the past 4 weeks |
5. Endotoxin activity assay ≥0.60 | 8. Subject has uncontrolled hemorrhage (acute blood loss requiring >3 Units of Packed red blood cellsin the past 24 hours) |
6. Evidence of at least one of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness | 9. Major trauma within 36 hours of screening |
a. Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube | 10. Subject has severe granulocytopenia (leukocyte count <500 cells/mm3) or severe thrombocytopenia (platelet count <30,000 cells/mm3) |
b. Thrombocytopenia defined as acute onset of platelet count <150,000 μ/L or a reduction of 50% from prior known levels | 11. HIV infection in association with a last known or suspected CD4 count of <50/mm3 |
c. Acute oliguria defined as urine output <0.5 ml/kg/hour for at least 6 hours despite adequate fluid resuscitation | 12. Subject’s baseline state is non-communicative |
13. Subject has sustained extensive third-degree burns within the past 7 days | |
14. Body weight <35 kg | |
15. Known hypersensitivity to polymyxin B | |
16. Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia | |
17. Subject is currently enrolled in an investigational drug or device trial | |
18. Subject has been previously enrolled in the current trial | |
19. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrolment, such as end stage chronic illness with no reasonable expectation of survival to hospital discharge | |
20. Multiple Organ Dysfunction Score ≤9 ** - added post-second interim analysis |