- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825329
Open-label Evaluation of Polymyxin B Hemoperfusion for Septic Shock (EUPHORIA)
Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDI-PMX-NA002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Septic Shock
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German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnUnknownSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockGermany
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University Medicine GreifswaldUnknownSepsis Septic ShockGermany
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Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
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McMaster UniversityCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated...Recruiting
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Assistance Publique - Hôpitaux de ParisCompletedSeptic Shock HyperdynamicFrance
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National Taiwan University HospitalBaxter Healthcare CorporationRecruiting
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Charite University, Berlin, GermanyCompleted
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Centre Hospitalier Universitaire DijonCompleted
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Mansoura UniversityUnknown
-
Rennes University HospitalTerminated
Clinical Trials on TORAYMYXIN PMX-20R
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Spectral Diagnostics (US) Inc.No longer availableSeptic Shock | Endotoxemia | COVID | Corona Virus Infection | Sepsis, SevereUnited States
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Spectral Diagnostics (US) Inc.RecruitingSeptic Shock | EndotoxemiaUnited States
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Spectral Diagnostics (US) Inc.CompletedSeptic Shock | EndotoxemiaUnited States, Canada
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Meditor SASCompletedSeptic Shock | PeritonitisFrance
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National Taiwan University HospitalCompleted
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National Taiwan University HospitalTerminated
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PolyMedix, Inc.TerminatedPercutaneous Coronary Intervention | Coronary Artery Disease (CAD) | AngioplastyUnited States
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University of ZurichCompletedPatients in Septic ShockSwitzerland
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PolyMedix, Inc.CompletedAcute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA) | (Susceptible or Methicillin Resistant)Canada, Russian Federation, Ukraine
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University of Turin, ItalyCompletedSepsis | Gram-Negative Bacterial InfectionsItaly