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 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:
✕. Acute pulmonary embolus
✕. Transfusion reaction
✕. Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction \< 35%)

Trial details

NCT IDNCT02825329

SponsorSpectral Diagnostics (US) Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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