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

NCT04352985 | Unknown

• 1 other identifier: SDI-PMX-013
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Septic Shock; Endotoxemia; COVID; Corona Virus Infection; Sepsis, Severe

Interventions

Toraymyxin PMX-20R (PMX Cartridge) DEVICE

The intervention is two (2) treatment sessions of PMX cartridge administration within approximately 24 hours of each other. Each treatment session 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). In cases where the clinical status of the subject is improving, or if the subject suffers from a relapse and the treating physician believes an additional PMX treatment may improve the clinical outcome of the subject, they may administer an additional PMX treatment session (for a total of 3 treatment sessions) at their discretion. All subjects will continue to receive standard medical care for COVID 19 and septic shock.

Eligibility Criteria

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

You may qualify if:

• 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
• The subject must have a screening multi-organ dysfunction score (MODS) \>9
• Endotoxin Activity Assay between ≥ 0.60 to \<0.90 EA 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 \<150,000µ/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

Study Sites (3)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Shock, Septic; Endotoxemia; Coronavirus Infections; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacteremia; Toxemia; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases

Study Design

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

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Last Updated: September 20, 2021

Record last verified: 2021-09

Locations

US (3)