Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomiz… (NCT03901807) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
United States150 participantsStarted 2020-01-09
Plain-language summary
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock
Who can participate
Age range18 Years
SexALL
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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
✕. Subject has end-stage renal disease and requires chronic dialysis
✕. There is clinical support for non-septic shock such as: