Septic ShockNCT04352985
Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19
A study testing Toraymyxin PMX-20R (PMX Cartridge) in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc. at 3 sites in United States.
Trial summary
Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Endotoxemia, COVID
- What is being tested?
- Toraymyxin PMX-20R (PMX Cartridge)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 3 sitesUnited States
- 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
- 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
- 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
- Positive COVID 19 diagnosis
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
3 sites in 1 country.
United States3 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030
Stony Brook University Hospital
Stony Brook, New York, 11794
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock
Read the detailed description
This is a compassionate use protocol for a population of patients with an immediately life-threatening condition, for whom no comparable alternative therapy options are available. The PMX cartridge will be utilized to treat critically ill patients with septic shock who also have COVID 19 virus. The objective will be to observe the efficacy of the PMX cartridge with a focus on safety of use in this population.
- Conditions
- Septic Shock, Endotoxemia, COVID, Corona Virus Infection, Sepsis, Severe
- Being tested
- Toraymyxin PMX-20R (PMX Cartridge)
- Medical subject headings
- Shock, Septic, Endotoxemia, Coronavirus Infections, Sepsis
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
The intervention is two (2) treatment sessions of PMX cartridge administration within approximately 24 hours of each other. Each treatment session 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). In cases where the clinical status of the subject is improving, or if the subject suffers from a relapse and the treating physician believes an additional PMX treatment may improve the clinical outcome of the subject, they may administer an additional PMX treatment session (for a total of 3 treatment sessions) at their discretion. All subjects will continue to receive standard medical care for COVID 19 and septic shock.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
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
- NCT04352985
- Sponsor's protocol ID
- SDI-PMX-013
- Status last verified
- Sep 2021
- First submitted
- 15 Apr 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19
- ClinicalTrials.gov ID
- NCT04352985
- Acronym / sponsor ID
- SDI-PMX-013
- Conditions
- Septic Shock, Endotoxemia, COVID, Corona Virus Infection, Sepsis, Severe
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Spectral Diagnostics (US) Inc.Industry (pharma, biotech, devices)
- First posted
- 20 Apr 2020 (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, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock
Detailed description
This is a compassionate use protocol for a population of patients with an immediately life-threatening condition, for whom no comparable alternative therapy options are available. The PMX cartridge will be utilized to treat critically ill patients with septic shock who also have COVID 19 virus. The objective will be to observe the efficacy of the PMX cartridge with a focus on safety of use in this population.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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
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 (PMX Cartridge)The intervention is two (2) treatment sessions of PMX cartridge administration within approximately 24 hours of each other. Each treatment session 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). In cases where the clinical status of the subject is improving, or if the subject suffers from a relapse and the treating physician believes an additional PMX treatment may improve the clinical outcome of the subject, they may administer an additional PMX treatment session (for a total of 3 treatment sessions) at their discretion. All subjects will continue to receive standard medical care for COVID 19 and septic shock. | 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 20 Sep 2021.
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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.
3 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 (PMX Cartridge) in people with Septic Shock and Endotoxemia, run by Spectral Diagnostics (US) Inc. at 3 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 17 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 20 Sep 2021.