Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
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
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge
Eligibility
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
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. The subject must have a screening multi-organ dysfunction score (MODS) >9 OR a
sequential organ failure assessment (SOFA) >11, in the event a complete MODS cannot be
obtained due to missing measurements
6. Endotoxin Activity Assay between ≥ 0.60 to <0.90 EA units
7. 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 <150,000µ/L or a
reduction of 50% from prior known levels
3. Acute oliguria defined as urine output <0.5mL/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 (eg. lack of source control and bowel necrosis) with no reasonable expectation
of survival to hospital discharge
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.