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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    15
  • sponsor
    Boa Biomedical, Inc.
Updated on 12 September 2021

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.

Description

This is a prospective, multi-center, single- arm study. Each subject will receive two (2) sessions of hemodialysis with the GARNET each of 3-4 hour duration at a blood flow rate of 250 to 400 mL/min. Any necessary dialysis treatment dosing prescription changes will be made by the treating physician, based on results of small molecule clearance (i.e., urea reduction ratio (URR)). After the second treatment session with the GARNET device, the subjects will resume their hemodialysis regimen using a standard hemodialyzer. Subjects will be followed for 30 days after the final treatment session to evaluate safety.

Details
Condition Bloodstream Infection
Treatment GARNET device
Clinical Study IdentifierNCT04658017
SponsorBoa Biomedical, Inc.
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

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
For a suspected central-line (temporary or tunneled central venous catheters) and non- central line (arterio-venous fistula and arterio-venous graft) vascular
infection
presence of at least one of the following signs or symptoms
fever (>38.0C), 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 > 101F (38.3C) or < 96.8F (36C)
Heart rate > 90 beats per minute
Respiratory rate > 20 breaths per minute
White blood cell count > 12,000/mm, < 4,000/mm, or > 10% bands
For confirmed infections
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
(>38.0C), 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

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/L)
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 mol/L)
Currently taking oral contraception
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