Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Septic Shock
- Sponsor
- Spectral Diagnostics (US) Inc.
- Status
- Temporarily Not Available
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
This is an open-label, non-controlled trial of standard medical care plus the TORAYMYXIN PMX-20R (PMX cartridge), in subjects with endotoxemia and septic shock. Subjects in ICUs will be assessed for septic shock using known or suspected infection and hypotension requiring vasopressor support as primary criteria. Endotoxemia will be assessed using the Endotoxin Activity Assay. Consented eligible subjects will receive two interventions with the PMX cartridge approximately 24 hours apart.The status of all subjects will be followed for 28 days, and long term follow-ups completed at 3 months, 6 months and 12 months. This is a continued access study subsequent to the EUPHRATES clinical trial NCT01046669.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who meet the following criteria (and have a signed informed consent) will be allowed into the study:
- •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
- •The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility
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%)
- •Subject has had chest compressions as part of CPR during this hospitalization without immediate return to communicative state
- •Subject has had an acute myocardial infarction (AMI) within the past 4 weeks
Outcomes
Primary Outcomes
Not specified