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Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock (EUPHORIA)

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ClinicalTrials.gov Identifier: NCT02825329
Expanded Access Status : Temporarily not available
First Posted : July 7, 2016
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Spectral Diagnostics (US) Inc.

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.

Condition or disease Intervention/treatment
Septic Shock Endotoxemia Device: TORAYMYXIN PMX-20R

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.

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock


Intervention Details:
  • Device: TORAYMYXIN PMX-20R
    Two (2) PMX cartridges will be administered approximately 24 hours apart. PMX Cartridge is an extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Subjects who meet the following criteria (and have a signed informed consent) will be allowed into the study:

  1. Age ≥18 years of age
  2. 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

    1. Norepinephrine > 0.05mcg/kg/min
    2. Dopamine > 10 mcg/kg/min
    3. Phenylephrine > 0.4 mcg/kg/min
    4. Epinephrine > 0.05 mcg/kg/min
    5. Vasopressin > 0.03 units/min
    6. Vasopressin (any dose) in combination with another vasopressor listed above
  3. The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility
  4. Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration
  5. Endotoxin Activity Assay ≥ 0.60 EAA units
  6. Evidence of at least 1 of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness

    1. Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube
    2. Thrombocytopenia defined as acute onset of platelet count < 150,000 μ/L or a reduction of 50% from prior known levels
    3. Acute oliguria defined as urine output < 0.5 ml/kg/hr for at least 6 hours despite adequate fluid resuscitation

Exclusion Criteria:

  1. Inability to obtain an informed consent from the subject, family member or an authorized surrogate
  2. Lack of commitment for full medical support
  3. Inability to achieve or maintain a minimum mean arterial pressure (MAP) of ≥ 65mmHg despite vasopressor therapy and fluid resuscitation
  4. Subject has end-stage renal disease and requires chronic dialysis
  5. There is clinical support for non-septic shock such as:

    1. Acute pulmonary embolus
    2. Transfusion reaction
    3. Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction < 35%)
  6. Subject has had chest compressions as part of CPR during this hospitalization without immediate return to communicative state
  7. Subject has had an acute myocardial infarction (AMI) within the past 4 weeks
  8. Subject has uncontrolled hemorrhage (acute blood loss requiring > 3 UPC in the past 24 hours)
  9. Major trauma within 36 hours of screening
  10. Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 30,000 cells/mm3)
  11. HIV infection in association with a last known or suspected CD4 count of <50/mm3
  12. Subject's baseline state is non-communicative
  13. Subject has sustained extensive third-degree burns within the past 7 days
  14. Body weight < 35 kg (77 pounds)
  15. Known hypersensitivity to Polymyxin B
  16. Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.)
  17. Subject is currently enrolled in an investigational drug or device trial
  18. Subject has been previously enrolled in the current trial
  19. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment, such as end-stage chronic illness with no reasonable expectation of survival to hospital discharge
  20. Subject has a screening MOD score ≤9

No Contacts or Locations Provided
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Responsible Party: Spectral Diagnostics (US) Inc.
ClinicalTrials.gov Identifier: NCT02825329    
Other Study ID Numbers: SDI-PMX-NA002
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Shock, Septic
Endotoxemia
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Bacteremia
Toxemia