CompletedNot Applicable

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

United States, Canada450 participantsStarted 2010-06

Plain-language summary

To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.

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: * 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

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.

What they're measuring

Mortality

Timeframe: 28 days

Trial details

NCT IDNCT01046669

SponsorSpectral Diagnostics (US) Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2018-10-24

View on ClinicalTrials.gov More Septic Shock trials

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.