Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

Sponsor
Spectral Diagnostics (US) Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT04352985
Collaborator
(none)
3

Study Details

Study Description

Brief Summary

Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock

Condition or Disease Intervention/Treatment Phase
  • Device: Toraymyxin PMX-20R (PMX Cartridge)

Detailed Description

This is a compassionate use protocol for a population of patients with an immediately life-threatening condition, for whom no comparable alternative therapy options are available. The PMX cartridge will be utilized to treat critically ill patients with septic shock who also have COVID 19 virus. The objective will be to observe the efficacy of the PMX cartridge with a focus on safety of use in this population.

Study Design

Study Type:
Expanded Access
Official Title:
Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    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

    3. Norepinephrine > 0.05mcg/kg/min

    4. Dopamine > 10 mcg/kg/min

    5. Phenylephrine > 0.4 mcg/kg/min

    6. Epinephrine > 0.05 mcg/kg/min

    7. Vasopressin > 0.03 units/min

    8. Vasopressin (any dose) in combination with another vasopressor listed above

    9. The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility

    10. Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration

    11. The subject must have a screening multi-organ dysfunction score (MODS) >9

    12. Endotoxin Activity Assay between ≥ 0.60 to <0.90 EA units

    13. Evidence of at least 1 of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness:

    14. Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube

    15. Thrombocytopenia defined as acute onset of platelet count <150,000µ/L or a reduction of 50% from prior known levels

    16. Acute oliguria defined as urine output <0.5mL/kg/hr for at least 6 hours despite adequate fluid resuscitation

    17. Positive COVID 19 diagnosis

    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:

    6. Acute pulmonary embolus

    7. Transfusion reaction

    8. Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction < 35%)

    9. Subject has had chest compressions as part of CPR during this hospitalization without immediate return to communicative state

    10. Subject has had an acute myocardial infarction (AMI) within the past 4 weeks

    11. Subject has uncontrolled hemorrhage (acute blood loss requiring > 3 UPC in the past 24 hours)

    12. Major trauma within 36 hours of screening

    13. Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 30,000 cells/mm3)

    14. HIV infection in association with a last known or suspected CD4 count of <50/mm3

    15. Subject's baseline state is non-communicative

    16. Subject has sustained extensive third-degree burns within the past 7 days

    17. Body weight < 35 kg (77 pounds)

    18. Known hypersensitivity to Polymyxin B

    19. Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.)

    20. Subject is currently enrolled in an investigational drug or device trial

    21. Subject has been previously enrolled in the current trial

    22. 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 (eg. lack of source control and bowel necrosis) with no reasonable expectation of survival to hospital discharge

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Connecticut Health Center Farmington Connecticut United States 06030
    2 George Washington University Washington District of Columbia United States 20052
    3 Stony Brook University Hospital Stony Brook New York United States 11794

    Sponsors and Collaborators

    • Spectral Diagnostics (US) Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Spectral Diagnostics (US) Inc.
    ClinicalTrials.gov Identifier:
    NCT04352985
    Other Study ID Numbers:
    • SDI-PMX-013
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 20, 2021