GARNET™ Filter (GARNET Device) IDE Used in Chronic Hemodialysis Patients With a Bloodstream Infec… (NCT04658017) | Clinical Trial Compass
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GARNETâ„¢ Filter (GARNET Device) IDE Used in Chronic Hemodialysis Patients With a Bloodstream Infection
United States15 participantsStarted 2021-03-15
Plain-language summary
To evaluate the feasibility of performing combined hemodialysis with the GARNET device in chronic hemodialysis patients with a blood stream infection (BSI), and measure clinical performance and safety endpoints.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Hospitalized adults (age ≥ 18 years and ≤ 90 years)
✓. Patients on chronic hemodialysis for ≥ 3 hours per treatment and a minimum of 3 times per week schedule
✓. Suspected or confirmed BSI as defined by:
✓. Body temperature \> 101°F (38.3°C) or \< 96.8°F (36°C);
✓. Heart rate \> 90 beats per minute;
✓. Respiratory rate \> 20 breaths per minute;
✓. White blood cell count \> 12,000/mm³, \< 4,000/mm³, or \> 10% bands
Exclusion criteria
✕. Pregnancy confirmed by positive urine or serum test, or lactating mothers
✕. Subject with severe concomitant disease expected to prolong hospitalization or cause death in ≤ 30 days, or terminal illness, or "do not resuscitate" code status
✕. Known sensitivity/allergy to heparin
✕. Known sensitivity/allergy to polyethersulfone dialyzers
✕. Active bleeding (e.g. active GI bleeding, hematuria or epistaxis, untreated coagulopathy or bleeding from a non-compressible site)
✕. Severe thrombocytopenia (platelet count \< 50,000/μL)
✕
What they're measuring
1
Safety - Rate of adjudicated device- or GARNET device procedure-related Serious Adverse Events (SAEs)
. Active enrollment in another study (patients enrolled in an observational study without any interventions or in post-market surveillance do not need to be excluded)
✕. Inability to achieve vascular access blood flow rates of ≥250mL/min during the previous dialysis treatment