Septic ShockEUPHRATESNCT01046669
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
A study testing TORAYMYXIN PMX-20R (PMX cartridge) and Standard medical care for septic shock in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc. at 40 sites in 2 countries.
Trial summary
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone. 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 (PMX cartridge) and Standard medical care for septic shock
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Jun 2010to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Hypotension requiring vasopressor support
- The subject must have received intravenous fluid resuscitation
- Documented or suspected infection
- Endotoxin Activity Assay ≥ 0.60 EAA units
- Evidence of at least 1 new onset organ dysfunction
Who cannot join
- Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
- Subject has end stage renal disease and requires chronic dialysis
- There is clinical support for non-septic shock
- Subject has had chest compressions as part of CPR
- Subject has had an acute myocardial infarction (AMI)
- Subject has uncontrolled hemorrhage
Show all 14Show fewer
- Major trauma within 36 hours of screening
- Subject has severe granulocytopenia
- HIV infection with a last known or suspected CD4 count of <50/mm3
- Subject has sustained extensive third-degree burns
- Body weight < 35 kg (77 pounds)
- Known hypersensitivity to polymyxin B
- Subject has known sensitivity or allergy to heparin
- Subject has screening MOD score of ≤9
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States33 sites
Study site
Ann Arbor, Michigan
Study site
Augusta, Georgia
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Camden, New Jersey
Study site
Chattanooga, Tennessee
Study site
Colorado Springs, Colorado
Study site
Columbus, Ohio
Study site
Detroit, Michigan
Study site
Greenville, North Carolina
Study site
Hazard, Kentucky
Study site
Houston, Texas
Study site
Idaho Falls, Idaho
Study site
Iowa City, Iowa
Study site
Jackson, Mississippi
Study site
Little Rock, Arkansas
Study site
Loma Linda, California
Study site
New York, New York
Study site
Newark, Delaware
Study site
Oak Park, Illinois
Study site
Omaha, Nebraska
Study site
Peoria, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Richmond, Virginia
Study site
Rochester, Minnesota
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
Stanford, California
Study site
Tucson, Arizona
Study site
Washington D.C., District of Columbia
Canada7 sites
Study site
Calgary, Alberta
Study site
Edmonton, Alberta
Study site
Oshawa, Ontario
Study site
Ottawa, Ontario
Study site
Québec, Quebec
Study site
Toronto, Ontario
Study site
Victoria, British Columbia
About this study
Official title: Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
- Conditions
- Septic Shock, Endotoxemia
- Being tested
- TORAYMYXIN PMX-20R (PMX cartridge), Standard medical care for septic shock
- Medical subject headings
- Shock, Septic, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORAYMYXIN PMX-20R (PMX cartridge)Device
TORAYMYXIN PMX-20R (PMX cartridge), 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).
Standard medical care for septic shockOther
Standard medical care for septic shock
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Standard medical care for septic shock Receives: Other: Standard medical care for septic shock |
| Treatment | Experimental | Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock Receives: Device: TORAYMYXIN PMX-20R (PMX cartridge); Other: Standard medical care for septic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectral Diagnostics (US) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip Dellinger, Dr., Principal investigator, Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046669
- Sponsor's protocol ID
- SDI-PMX-NA001
- Acronym
- EUPHRATES
- Status last verified
- Feb 2019
- First submitted
- 8 Jan 2010
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chanderraj R, Bartek B, Stringer KA, Tiba MH, Sjoding MW, He Y, Nuppnau M, Bongers KS, Adame MD, Lou SS, Kerschberger VE, Churpek MM, Calfee CS, Tripathi S, Foster DM, Kellum JA, Dickson RP, Sinha P. Pathogen characteristics are key determinants of distinct host response phenotypes of sepsis. J Clin Invest. 2026 Mar 16;136(6):e197346. doi: 10.1172/JCI197346. eCollection 2026 Mar 16.
PubMed 41837287Klein DJ, Foster D, Walker PM, Bagshaw SM, Mekonnen H, Antonelli M. Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23.
PubMed 30470853Dellinger RP, Bagshaw SM, Antonelli M, Foster DM, Klein DJ, Marshall JC, Palevsky PM, Weisberg LS, Schorr CA, Trzeciak S, Walker PM; EUPHRATES Trial Investigators. Effect of Targeted Polymyxin B Hemoperfusion on 28-Day Mortality in Patients With Septic Shock and Elevated Endotoxin Level: The EUPHRATES Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1455-1463. doi: 10.1001/jama.2018.14618.
PubMed 30304428Klein DJ, Foster D, Schorr CA, Kazempour K, Walker PM, Dellinger RP. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:218. doi: 10.1186/1745-6215-15-218.
PubMed 24916483
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
- ClinicalTrials.gov ID
- NCT01046669
- Acronym / sponsor ID
- EUPHRATES / SDI-PMX-NA001
- Conditions
- Septic Shock, Endotoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Spectral Diagnostics (US) Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Posted 6 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Standard medical care for septic shockStandard medical care for septic shock |
| Treatment | Experimental | Device: TORAYMYXIN PMX-20R (PMX cartridge), Other: Standard medical care for septic shockTwo (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hypotension requiring vasopressor support
- The subject must have received intravenous fluid resuscitation
- Documented or suspected infection
- Endotoxin Activity Assay ≥ 0.60 EAA units
- Evidence of at least 1 new onset organ dysfunction
Key exclusion criteria (14 listed)
- Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
- Subject has end stage renal disease and requires chronic dialysis
- There is clinical support for non-septic shock
- Subject has had chest compressions as part of CPR
- Subject has had an acute myocardial infarction (AMI)
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 (PMX cartridge)TORAYMYXIN PMX-20R (PMX cartridge), 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). | Device | Treatment |
| Standard medical care for septic shockStandard medical care for septic shock | Other | Control, Treatment |
Primary outcome
Mortality
Time frame: 28 days
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41837287Chanderraj R, Bartek B, Stringer KA, Tiba MH, Sjoding MW, He Y, Nuppnau M, Bongers KS, Adame MD, Lou SS, Kerschberger VE, Churpek MM, Calfee CS, Tripathi S, Foster DM, Kellum JA, Dickson RP, Sinha P. Pathogen characteristics are key determinants of distinct host response phenotypes of sepsis. J Clin Invest. 2026 Mar 16;136(6):e197346. doi: 10.1172/JCI197346. eCollection 2026 Mar 16.
- Derived from this study: PubMed 30470853Klein DJ, Foster D, Walker PM, Bagshaw SM, Mekonnen H, Antonelli M. Polymyxin B hemoperfusion in endotoxemic septic shock patients without extreme endotoxemia: a post hoc analysis of the EUPHRATES trial. Intensive Care Med. 2018 Dec;44(12):2205-2212. doi: 10.1007/s00134-018-5463-7. Epub 2018 Nov 23.
- Derived from this study: PubMed 30304428Dellinger RP, Bagshaw SM, Antonelli M, Foster DM, Klein DJ, Marshall JC, Palevsky PM, Weisberg LS, Schorr CA, Trzeciak S, Walker PM; EUPHRATES Trial Investigators. Effect of Targeted Polymyxin B Hemoperfusion on 28-Day Mortality in Patients With Septic Shock and Elevated Endotoxin Level: The EUPHRATES Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1455-1463. doi: 10.1001/jama.2018.14618.
- Derived from this study: PubMed 24916483Klein DJ, Foster D, Schorr CA, Kazempour K, Walker PM, Dellinger RP. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:218. doi: 10.1186/1745-6215-15-218.
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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.
Phillip Dellinger, Dr. principal investigator
Cooper Health System
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TORAYMYXIN PMX-20R (PMX cartridge) and Standard medical care for septic shock in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc. at 40 sites in 2 countries.
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 5 inclusion and 14 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mortality (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 NCT01046669, which also lists 4 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 26 Feb 2019.