Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01046669
Eligibility Criteria:
Inclusion Criteria:
* Hypotension requiring vasopressor support
* The subject must have received intravenous fluid resuscitation
* Documented or suspected infection
* Endotoxin Activity Assay ≥ 0.60 EAA units
* Evidence of at least 1 new onset organ dysfunction
Exclusion Criteria:
* Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
* Subject has end stage renal disease and requires chronic dialysis
* There is clinical support for non-septic shock
* Subject has had chest compressions as part of CPR
* Subject has had an acute myocardial infarction (AMI)
* Subject has uncontrolled hemorrhage
* Major trauma within 36 hours of screening
* Subject has severe granulocytopenia
* HIV infection with a last known or suspected CD4 count of \<50/mm3
* Subject has sustained extensive third-degree burns
* Body weight \< 35 kg (77 pounds)
* Known hypersensitivity to polymyxin B
* Subject has known sensitivity or allergy to heparin
* Subject has screening MOD score of ≤9
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01046669
Study Brief:
Protocol Section:
NCT01046669