GARNET™ Filter (GARNET Device) IDE Used in Chronic Hemodialysis Patients With a Bloodstream Infection

Status unconfirmed · Not applicable

Conditions studied: Bloodstream Infection

In brief

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.

Key facts

Study ID

NCT04658017

Run by

Boa Biomedical, Inc.

People needed

15

Starts

2021-03-15

Expected to finish

2021-12-31

Last updated by the study team

2021-09-05

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• a. For a suspected central-line (temporary or tunneled central venous catheters) and non- central line (arterio-venous fistula and arterio-venous graft) vascular infection:
• i. presence of at least one of the following signs or symptoms:
• fever (>38.0°C), 2. pain*, 3. erythema*, or 4. heat at involved vascular site* (*with no other recognized cause); or
• ii. presence of purulent drainage/pus at the vascular site, in accordance with the CDC/NHSN Surveillance Definitions for Specific Types of Infections
• b. For other suspected infections:
• i. presence of at least 2 of the 4 SIRS criteria:
• 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
• c. For confirmed infections:
• i. laboratory-confirmed BSI based on the isolation of an organism from blood cultures; or
• ii. If a laboratory-confirmed BSI due to a commensal organism, the presence of at least one of the following signs or symptoms will be required: fever (>38.0˚C), chills, or hypotension.
• Subject agrees to comply with all follow-up evaluations
• Subject has provided written informed consent; or if unable to perform informed consent, written informed consent on behalf of the subject has been provided by a legally-authorized representative.

You may not qualify if…

• 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)
• 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
• Requirement for Continuous Renal Replacement Therapy/Sustained Low Efficiency Dialysis (CRRT/SLED) due to hemodynamic instability
• Hemodynamic instability
• Medical conditions requiring regular blood transfusion
• Hypocalcemia or clinical symptoms of hypocalcemia at time of enrollment
• History of or known hypercoagulable state (e.g. Systemic Lupus Erythematosus (SLE), antiphospholipid syndrome/lupus anticoagulant, protein C or S deficiency, antithrombin deficiency, factor V Leiden deficiency, active cancer, sickle cell disease, and history of deep vein thrombosis (DVT))
• History of a condition documented in the medical record within 6 months prior to enrollment that may result in an increased risk for thrombosis, including any of the following:
• Multiple incidents (≥ 2) of unresolvable thrombosis-induced catheter malfunctions which required catheter exchange, occurring within the 6 months prior to enrollment
• Prior history of renal transplant thrombosis
• Elevated Factor VIII with or without familial hypercholesterolemia
• Hyperhomocysteinemia with a homocysteine level of >4 mg/L (17.2 μmol/L)
• Currently taking oral contraception

Where it is running

• University of Maryland at Baltimore — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• George Washington University — Washington D.C., District of Columbia, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Houston Methodist — Houston, Texas, United States

Full record on ClinicalTrials.gov

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