Safety And Efficacy Of Polymyxin B Hemoperfusion (PMX) For Septic Shock
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 10-005551
NCT ID: NCT01046669
Sponsor Protocol Number: SDI-PMX-NA001
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available