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Blood filter aims to pull toxins from septic shock patients

NCT ID NCT03901807

Disease control Sponsor: Spectral Diagnostics (US) Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a device called the PMX cartridge, which filters endotoxins from the blood, can improve survival in people with septic shock. About 150 adults with severe infections and low blood pressure will receive either standard care alone or standard care plus the PMX cartridge. The main goal is to see if the device reduces deaths within 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Toraymyxin PMX 20R extracorporeal hemoperfusion cartridge (a blood-filtering device that removes endotoxin)
What this could lead to
If it works, this could provide a new treatment option to reduce early death in septic shock patients with endotoxemia.
What could go wrong
This is a mid-stage trial with only 150 participants, so results may not apply to all septic shock patients. The device is invasive and carries risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2020

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Endotoxemia Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endotoxemia Septic shock

Contacts and locations

Locations

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • CHI Memorial

    Chattanooga, Tennessee, 37404, United States

  • Cooper Health System

    Camden, New Jersey, 08103, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Institute for Extracorporeal Life Support

    San Antonio, Texas, 78229, United States

  • Louisiana State University Health Shreveport

    Shreveport, Louisiana, 71103, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mt Sinai Hospital

    New York, New York, 10029, United States

  • Parkridge Hospital

    Chattanooga, Tennessee, 37404, United States

  • Pulmonary Associates

    Boulder, Colorado, 80909, United States

  • Rutgers, The State University of New Jersey

    Piscataway, New Jersey, 08854, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0111, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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