Septic Shock Clinical Trial
— TIGRISOfficial title:
A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock
Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age =18 years of age 2. 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 1. Norepinephrine > 0.05mcg/kg/min 2. Dopamine > 10 mcg/kg/min 3. Phenylephrine > 0.4 mcg/kg/min 4. Epinephrine > 0.05 mcg/kg/min 5. Vasopressin > 0.03 units/min 6. Vasopressin (any dose) in combination with another vasopressor listed above 3. The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility 4. Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration 5. The subject must have a screening multi-organ dysfunction score (MODS) >9 OR a sequential organ failure assessment (SOFA) >11, in the event a complete MODS cannot be obtained due to missing measurements 6. Endotoxin Activity Assay between = 0.60 to <0.90 EA units 7. Evidence of at least 1 of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness: 1. Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube 2. Thrombocytopenia defined as acute onset of platelet count <150,000µ/L or a reduction of 50% from prior known levels 3. Acute oliguria defined as urine output <0.5mL/kg/hr for at least 6 hours despite adequate fluid resuscitation Exclusion Criteria: 1. Inability to obtain an informed consent from the subject, family member or an authorized surrogate 2. Lack of commitment for full medical support 3. Inability to achieve or maintain a minimum mean arterial pressure (MAP) of = 65mmHg despite vasopressor therapy and fluid resuscitation 4. Subject has end-stage renal disease and requires chronic dialysis 5. There is clinical support for non-septic shock such as: 1. Acute pulmonary embolus 2. Transfusion reaction 3. Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction < 35%) 6. Subject has had chest compressions as part of CPR during this hospitalization without immediate return to communicative state 7. Subject has had an acute myocardial infarction (AMI) within the past 4 weeks 8. Subject has uncontrolled hemorrhage (acute blood loss requiring > 3 UPC in the past 24 hours) 9. Major trauma within 36 hours of screening 10. Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 30,000 cells/mm3) 11. HIV infection in association with a last known or suspected CD4 count of <50/mm3 12. Subject's baseline state is non-communicative 13. Subject has sustained extensive third-degree burns within the past 7 days 14. Body weight < 35 kg (77 pounds) 15. Known hypersensitivity to Polymyxin B 16. Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.) 17. Subject is currently enrolled in an investigational drug or device trial 18. Subject has been previously enrolled in the current trial 19. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Pulmonary Associates | Boulder | Colorado |
United States | Cooper Health System | Camden | New Jersey |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | CHI Memorial | Chattanooga | Tennessee |
United States | Parkridge Hospital | Chattanooga | Tennessee |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | West Virginia University | Morgantown | West Virginia |
United States | Mt Sinai Hospital | New York | New York |
United States | Stanford University | Palo Alto | California |
United States | UPMC | Pittsburgh | Pennsylvania |
United States | Washington University | Saint Louis | Missouri |
United States | University of California, San Francisco | San Francisco | California |
United States | Louisiana State University Health Shreveport | Shreveport | Louisiana |
United States | Baystate Medical Center | Springfield | Massachusetts |
United States | Stony Brook University | Stony Brook | New York |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Spectral Diagnostics (US) Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Day 28 mortality comparison | The primary objective is to compare the safety and efficacy of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone. | 28 days | |
Secondary | MAP comparison | compare changes in mean arterial blood pressure (MAP) from Day 0 to Day 3 in each group | 3 days | |
Secondary | Vasopressor dose comparison | compare the changes in vasopressor doses from Day 0 to Day 3 in each group | 3 days | |
Secondary | Survival time comparison | compare the survival time from baseline to death within 28 days in each group | 28 days | |
Secondary | Day 28 mortality comparison for patients on norepinephrine >0.1 mcg/kg/min | compare mortality at 28 days post baseline for patients with baseline norepinephrine dose >0.1 mcg/kg/min in each group | 28 days | |
Secondary | Day 14 mortality comparison | compare mortality at 14 days post baseline in each group | 14 days | |
Secondary | Vasopressor use comparison | compare total duration of vasopressor use from Day 0 to Day 3 in each group | 3 days |
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