- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352985
Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19
September 13, 2021 updated by: Spectral Diagnostics (US) Inc.
Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock
Study Overview
Status
No longer available
Intervention / Treatment
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 Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20052
- George Washington University
-
-
New York
-
Stony Brook, New York, United States, 11794
- Stony Brook University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
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 (eg. lack of source control and bowel necrosis) with no reasonable expectation of survival to hospital discharge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 15, 2020
First Submitted That Met QC Criteria
April 15, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDI-PMX-013
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
-
German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnUnknownSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockGermany
-
University Medicine GreifswaldUnknownSepsis Septic ShockGermany
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated...Recruiting
-
Assistance Publique - Hôpitaux de ParisCompletedSeptic Shock HyperdynamicFrance
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
National Taiwan University HospitalBaxter Healthcare CorporationRecruiting
-
Charite University, Berlin, GermanyCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Mansoura UniversityUnknown
-
University of ZurichCompletedPatients in Septic ShockSwitzerland
Clinical Trials on Toraymyxin PMX-20R (PMX Cartridge)
-
Spectral Diagnostics (US) Inc.RecruitingSeptic Shock | EndotoxemiaUnited States
-
Spectral Diagnostics (US) Inc.CompletedSeptic Shock | EndotoxemiaUnited States, Canada
-
Spectral Diagnostics (US) Inc.Temporarily not availableSeptic Shock | Endotoxemia
-
Meditor SASCompletedSeptic Shock | PeritonitisFrance
-
National Taiwan University HospitalCompleted
-
PolyMedix, Inc.TerminatedPercutaneous Coronary Intervention | Coronary Artery Disease (CAD) | AngioplastyUnited States
-
PolyMedix, Inc.CompletedAcute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA) | (Susceptible or Methicillin Resistant)Canada, Russian Federation, Ukraine
-
University of Turin, ItalyCompletedSepsis | Gram-Negative Bacterial InfectionsItaly
-
Petrovsky National Research Centre of SurgeryRecruitingMultiple Organ Dysfunction With Severe EndotoxemiaRussian Federation