Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock (NCT02825329) | Clinical Trial Compass
TEMPORARILY_NOT_AVAILABLENot Applicable
Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock
Plain-language summary
Open-label, non-controlled study of standard care plus the TORAYMYXIN PMX-20R (PMX cartridge) in subjects who have endotoxemia and septic shock. This is a continued access study subsequent to the EUPHRATES clinical trial NCT01046669.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years of age
. 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
. Norepinephrine \> 0.05mcg/kg/min
. Dopamine \> 10 mcg/kg/min
. Phenylephrine \> 0.4 mcg/kg/min
. Epinephrine \> 0.05 mcg/kg/min
. Vasopressin \> 0.03 units/min
. Vasopressin (any dose) in combination with another vasopressor listed above
Exclusion criteria
. Inability to obtain an informed consent from the subject, family member or an authorized surrogate
. Lack of commitment for full medical support
. Inability to achieve or maintain a minimum mean arterial pressure (MAP) of ≥ 65mmHg despite vasopressor therapy and fluid resuscitation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.