Septic ShockTIGRISNCT03901807
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
A study testing Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc. at 20 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Endotoxemia
- What is being tested?
- Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 20 sitesUnited States
- Study dates
- 9 Jan 2020to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 OR a sequential organ failure assessment (SOFA) >11, in the event a complete MODS cannot be obtained due to missing measurements
- 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
- Acute oliguria defined as urine output <0.5mL/kg/hr for at least 6 hours despite adequate fluid resuscitation
Who cannot join
- 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
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- 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
- Subject has sustained extensive third-degree burns within the past 7 days
- Body weight < 35 kg (77 pounds)
- Known hypersensitivity to Polymyxin B
- Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.)
- Subject is currently enrolled in an investigational drug or device trial
- Subject has been previously enrolled in the current trial
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0111
Pulmonary Associates
Boulder, Colorado, 80909
Cooper Health System
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
CHI Memorial
Chattanooga, Tennessee, 37404
Parkridge Hospital
Chattanooga, Tennessee, 37404
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Mt Sinai Hospital
New York, New York, 10029
Rutgers, The State University of New Jersey
Piscataway, New Jersey, 08854
UPMC
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Institute for Extracorporeal Life Support
San Antonio, Texas, 78229
University of California, San Francisco
San Francisco, California, 94143
Louisiana State University Health Shreveport
Shreveport, Louisiana, 71103
Baystate Medical Center
Springfield, Massachusetts, 01199
Stony Brook University
Stony Brook, New York, 11794
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock
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
Read the detailed description
This is a prospective, multicenter, randomized, open-label trial of standard medical care plus the PMX cartridge versus standard medical care alone, in subjects with endotoxemia and septic shock. Subjects in critical care areas will be assessed for septic shock using known or suspected infection, multiple organ failure, fluid resuscitation and hypotension requiring vasopressor support as primary criteria. Subjects will meet all entry criteria for study if endotoxin activity is within the range of ≥ 0.60 to <0.90.
Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all randomized subjects, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized.
- Conditions
- Septic Shock, Endotoxemia
- Being tested
- Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge
- Keywords
- sepsis, septic shock, severe sepsis, endotoxemia, endotoxemic, TIGRIS, PMX, Toraymyxin, EAA, Spectral Medical
- Medical subject headings
- Shock, Septic, Endotoxemia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toraymyxin PMX 20R Extracorporeal Hemoperfusion CartridgeDevice
TORAYMYXIN PMX-20R (PMX) is an extracorporeal hemoperfusion cartridge intended for the selective removal of endotoxin from circulating blood through direct hemoperfusion (DHP). 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).
| Study group | Role | What they receive |
|---|---|---|
| PMX Treatment | Experimental | Standard medical care for septic shock plus treatment with the PMX cartridge (twice approximately 24 hours apart) Receives: Device: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge |
| Control | No intervention | Standard medical care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28 mortality comparison
The primary objective is to compare the safety and efficacy of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone.
Measured: 28 days
Secondary outcomes (8)
Day 90 mortality comparison
compare mortality at 90 days post baseline in each group
Measured: 90 days
MAP comparison
compare changes in mean arterial blood pressure (MAP) from Day 0 to Day 3 in each group
Measured: 3 days
Vasopressor dose comparison
compare the changes in vasopressor doses from Day 0 to Day 3 in each group
Measured: 3 days
Survival time comparison
compare the survival time from baseline to death within 28 days in each group
Measured: 28 days
Day 28 mortality comparison for patients on norepinephrine >0.1 mcg/kg/min
compare mortality at 28 days post baseline for patients with baseline norepinephrine dose >0.1 mcg/kg/min in each group
Measured: 28 days
Day 14 mortality comparison
compare mortality at 14 days post baseline in each group
Measured: 14 days
Vasopressor use comparison
compare total duration of vasopressor use from Day 0 to Day 3 in each group
Measured: 3 days
12 month mortality comparison
compare mortality at 12 months post baseline in each group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start9 Jan 2020
- Primary completion8 May 2025
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be randomized in a 2:1 ratio to the two groups (PMX cartridge plus standard of care: standard of care alone). A blocked randomization scheme will be used to provide approximately balanced ratio allocations to the two groups for each investigative site during the study.
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectral Diagnostics (US) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901807
- Sponsor's protocol ID
- SDI-PMX-NA003
- Acronym
- TIGRIS
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans for sharing IPD at this time.
Publications
Neyra JA, Legrand M, Tidswell MA, Al-Khafaji A, Galphin C, Rains R, Davison D, Tolwani A, Chen JT, Bender WS, Busse LW, Meena NK, DellaVolpe J, Williams GW, Kashani KB, Gunnerson KJ, McMahon BA, Eaton J, Khan S, Kohli-Seth R, Jagpal S, Klein D, Kamaluddin E, Foster DM, Walker PM, Tomlinson G, Kellum JA. Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial. Lancet Respir Med. 2026 May;14(5):443-452. doi: 10.1016/S2213-2600(26)00047-0. Epub 2026 Mar 23.
PubMed 41887242Bellomo R, Mehta RL, Forni LG, Zarbock A, Ostermann M, Ronco C; Acute Disease Quality Initiative Hemoadsorption Working Group. Hemoadsorption. Clin J Am Soc Nephrol. 2024 Jan 12;19(6):803-806. doi: 10.2215/CJN.0000000000000433. Epub 2024 Jan 12. No abstract available.
PubMed 38214917
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock
- ClinicalTrials.gov ID
- NCT03901807
- Acronym / sponsor ID
- TIGRIS / SDI-PMX-NA003
- Conditions
- Septic Shock, Endotoxemia
- Keywords
- sepsis, septic shock, severe sepsis, endotoxemia, endotoxemic, TIGRIS, PMX, Toraymyxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Spectral Diagnostics (US) Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a prospective, multicenter, randomized, open-label trial of standard medical care plus the PMX cartridge versus standard medical care alone, in subjects with endotoxemia and septic shock. Subjects in critical care areas will be assessed for septic shock using known or suspected infection, multiple organ failure, fluid resuscitation and hypotension requiring vasopressor support as primary criteria. Subjects will meet all entry criteria for study if endotoxin activity is within the range of ≥ 0.60 to <0.90.
Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all randomized subjects, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The subjects will be randomized in a 2:1 ratio to the two groups (PMX cartridge plus standard of care: standard of care alone). A blocked randomization scheme will be used to provide approximately balanced ratio allocations to the two groups for each investigative site during the study.
| Arm | Type | Receives |
|---|---|---|
| PMX Treatment | Experimental | Device: Toraymyxin PMX 20R Extracorporeal Hemoperfusion CartridgeStandard medical care for septic shock plus treatment with the PMX cartridge (twice approximately 24 hours apart) |
| Control | No intervention | –Standard medical care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- 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 OR a sequential organ failure assessment (SOFA) >11, in the event a complete MODS cannot be obtained due to missing measurements
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toraymyxin PMX 20R Extracorporeal Hemoperfusion CartridgeTORAYMYXIN PMX-20R (PMX) is an extracorporeal hemoperfusion cartridge intended for the selective removal of endotoxin from circulating blood through direct hemoperfusion (DHP). 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). | Device | PMX Treatment |
Primary outcome
Day 28 mortality comparison
Time frame: 28 days
The primary objective is to compare the safety and efficacy of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone.
8 secondary outcomes
Day 90 mortality comparison
Time frame: 90 days
MAP comparison
Time frame: 3 days
Vasopressor dose comparison
Time frame: 3 days
Survival time comparison
Time frame: 28 days
Day 28 mortality comparison for patients on norepinephrine >0.1 mcg/kg/min
Time frame: 28 days
Day 14 mortality comparison
Time frame: 14 days
Vasopressor use comparison
Time frame: 3 days
12 month mortality comparison
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 41887242Neyra JA, Legrand M, Tidswell MA, Al-Khafaji A, Galphin C, Rains R, Davison D, Tolwani A, Chen JT, Bender WS, Busse LW, Meena NK, DellaVolpe J, Williams GW, Kashani KB, Gunnerson KJ, McMahon BA, Eaton J, Khan S, Kohli-Seth R, Jagpal S, Klein D, Kamaluddin E, Foster DM, Walker PM, Tomlinson G, Kellum JA. Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial. Lancet Respir Med. 2026 May;14(5):443-452. doi: 10.1016/S2213-2600(26)00047-0. Epub 2026 Mar 23.
- Derived from this study: PubMed 38214917Bellomo R, Mehta RL, Forni LG, Zarbock A, Ostermann M, Ronco C; Acute Disease Quality Initiative Hemoadsorption Working Group. Hemoadsorption. Clin J Am Soc Nephrol. 2024 Jan 12;19(6):803-806. doi: 10.2215/CJN.0000000000000433. Epub 2024 Jan 12. No abstract available.
- Individual participant dataSharing planned: No. There are no plans for sharing IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 28 mortality comparison (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901807, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.