Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock

NCT02825329 | Unknown

• 1 other identifier: SDI-PMX-NA002
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock; Endotoxemia

Interventions

TORAYMYXIN PMX-20R DEVICE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration
• Endotoxin Activity Assay ≥ 0.60 EAA units
• Evidence of at least 1 of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness
• Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube
• Thrombocytopenia defined as acute onset of platelet count \< 150,000 μ/L or a reduction of 50% from prior known levels

You may not qualify if:

• 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
• Subject has uncontrolled hemorrhage (acute blood loss requiring \> 3 UPC in the past 24 hours)
• Major trauma within 36 hours of screening
• Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 30,000 cells/mm3)
• HIV infection in association with a last known or suspected CD4 count of \<50/mm3
• Subject's baseline state is non-communicative

Sponsors & Collaborators

• Spectral Diagnostics (US) Inc.: lead

MeSH Terms

Conditions

Shock, Septic; Endotoxemia

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacteremia; Toxemia

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 7, 2016
• Last Updated: September 14, 2021

Record last verified: 2021-09