Septic ShockEUPHORIANCT02825329
Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock
A study testing TORAYMYXIN PMX-20R in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc..
Trial 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. 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
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
- Acute oliguria defined as urine output < 0.5 ml/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
Show all 23Show fewer
- 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 with no reasonable expectation of survival to hospital discharge
- Subject has a screening MOD score ≤9
About this study
Official title: Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults
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.
Read the detailed description
This is an open-label, non-controlled trial of standard medical care plus the TORAYMYXIN PMX-20R (PMX cartridge), in subjects with endotoxemia and septic shock. Subjects in ICUs will be assessed for septic shock using known or suspected infection and hypotension requiring vasopressor support as primary criteria. Endotoxemia will be assessed using the Endotoxin Activity Assay. Consented eligible subjects will receive two interventions with the PMX cartridge approximately 24 hours apart.The status of all subjects will be followed for 28 days, and long term follow-ups completed at 3 months, 6 months and 12 months.
This is a continued access study subsequent to the EUPHRATES clinical trial NCT01046669.
- Conditions
- Septic Shock, Endotoxemia
- Being tested
- TORAYMYXIN PMX-20R
- 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-20RDevice
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
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
- NCT02825329
- Sponsor's protocol ID
- SDI-PMX-NA002
- Acronym
- EUPHORIA
- Status last verified
- Sep 2021
- First submitted
- 4 Jul 2016
- Last updated
- 14 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults
- ClinicalTrials.gov ID
- NCT02825329
- Acronym / sponsor ID
- EUPHORIA / SDI-PMX-NA002
- Conditions
- Septic Shock, Endotoxemia
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Spectral Diagnostics (US) Inc.Industry (pharma, biotech, devices)
- First posted
- 7 Jul 2016 (estimated)
- 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.
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.
Detailed description
This is an open-label, non-controlled trial of standard medical care plus the TORAYMYXIN PMX-20R (PMX cartridge), in subjects with endotoxemia and septic shock. Subjects in ICUs will be assessed for septic shock using known or suspected infection and hypotension requiring vasopressor support as primary criteria. Endotoxemia will be assessed using the Endotoxin Activity Assay. Consented eligible subjects will receive two interventions with the PMX cartridge approximately 24 hours apart.The status of all subjects will be followed for 28 days, and long term follow-ups completed at 3 months, 6 months and 12 months.
This is a continued access study subsequent to the EUPHRATES clinical trial NCT01046669.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- 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
Key exclusion criteria (23 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-20RTwo (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). | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Questions about this trial
What is this clinical trial studying?
A study testing TORAYMYXIN PMX-20R in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc..
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 23 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: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 14 Sep 2021.