Septic Shock Clinical Trial
— PURIFY-RCTOfficial title:
Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial
This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: - The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation - Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Admitted to an ICU with pathogen associated shock defined as: - The need for vasopressors to maintain mean arterial pressure (MAP) = 65 mmHg despite adequate fluid resuscitation, AND - Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing 2. Male or non-pregnant female adult 3. At least 18 years of age at time of enrollment Exclusion Criteria: 1. Pregnant or breast feeding 2. Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason 3. Not anticipated to survive more than 24 hours 4. Known allergy to heparin sodium 5. Patients who cannot tolerate placement of double-lumen catheter 6. High risk of bleeding (platelet count <50mm3 or International Normalized Ratio (INR) >2) unless adequate line for treatment already placed (e.g. ECMO or RRT/CRRT) 7. Inability to tolerate extracorporeal therapy (defined as MAP<65 despite fluids and vasopressors) 8. Advanced cancer (defined as stage IV) with life expectancy of less than 30 days 9. Unable to obtain informed consent from either patient or legally authorized representative (LAR) 10. Hypotension and volume depletion due to etiologies other than sepsis. 11. Neutropenia with an absolute neutrophil count <500mm3 12. Patients must be treated with one of the antimicrobial agents listed in the Antimicrobial Management Guideline (Table 19). Patients who require treatment with an antimicrobial outside of this list while still receiving treatment with the investigational device must be excluded from the study. 13. If a patient enters the study and later requires a change in the antimicrobial agent used to one which is not listed in the Antimicrobial Management Guideline while still receiving treatment with the investigational device, that patient must be removed from this trial. Clinical data for any patient removed from the trial for this reason will continue to be collected for safety evaluation". 14. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee. 15. Advanced directive for "Do Not Resuscitate". |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Southeast Georgia Health System, Inc. | Brunswick | Georgia |
United States | Good Samaritan Hospital | Corvallis | Oregon |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Trinity Health Mid Atlantic-SMMC | Langhorne | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Methodist Hospital | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio (UT Health San Antonio) | San Antonio | Texas |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
ExThera Medical Corporation | Uniformed Services University of the Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy - ICU-free days in the first 28 days | Alive and not in the ICU (for at least a fulle 24 hours) in the first 28 days from the time of randomization | First 28 days | |
Primary | Safety - Adverse Events | SAEs and >/= grade 3 AEs per CTCAE v5 evaluated from enrollment until the end of hospitalization | Discharge from hospital | |
Secondary | Mortality | Evaluate in-hospital mortality and mortality at 28 days | 28 days | |
Secondary | Ventilator-free days in the first 28 days | Alive and free of mechanical ventilation (for at least a full 24 hours) in the first 28 days from the time of randomization | First 28 days | |
Secondary | Vasopressor-free days in the first 28 days | Alive and vasopressor-free for at least a 24-hour period in the first 28 days from the time of randomization | First 28 days | |
Secondary | Kidney replacement therapy-free days in the first 28 days | Alive and not on kidney replacement therapy for at least 72 hours. | First 28 days | |
Secondary | Hospital Stay | number of days that the subject is hospitalized | through study completion, an average of 90 days | |
Secondary | Survival | Alive or dead 90 days after enrollment (if discharged from the hospital prior to 90 days after enrollment) | through study completion, an average of 90 days |
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