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

Sponsor

Boa Biomedical, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04658017

Collaborator

Avania (Industry)

Enrollment

Locations

Arm

9.6

Anticipated Duration (Months)

2.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bloodstream Infection	Device: GARNET device	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All enrolled subjects will receive treatment with the GARNET deviceAll enrolled subjects will receive treatment with the GARNET device

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of Hemodialysis With the GARNET Device in Chronic Hemodialysis Patients With a Bloodstream Infection

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Oct 15, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GARNET device All enrolled subjects will receive treatment with the GARNET device.	Device: GARNET device Use of new filter in conjunction with standard of care dialysis.

Arm

Intervention/Treatment

Experimental: GARNET device

All enrolled subjects will receive treatment with the GARNET device.

Device: GARNET device

Use of new filter in conjunction with standard of care dialysis.

Outcome Measures

Primary Outcome Measures

Safety - Rate of adjudicated device- or GARNET device procedure-related Serious Adverse Events (SAEs) [30-day follow-up post-2nd GARNET device treatment]
Rate of adjudicated device or GARNET device procedure-related Serious Adverse Events (SAEs) All primary safety endpoints will be reported as adjudicated by the designated Clinical Events Committee (CEC) during treatment and through the 30-day follow-up period.

Secondary Outcome Measures

Resolution of Blood Stream Infection at 30-days post 2nd GARNET device treatment [30-day follow-up post-2nd GARNET device treatment]
• Resolution of Blood Stream Infection
Clearance for small (blood urea nitrogen) and middle (beta-2-microglobulin) molecule solutes by the GARNET device, as measured by the intra-dialytic urea and beta-2-microglobulin reduction ratio. [During Week 1 participation - Day 0: pre and post first GARNET device treatment and pre and post second GARNET device treatment which must occur by Day 7.]
• Extent of clearance of solutes (small and middle molecules)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 (>38.0°C), 2. pain*, 3. erythema*, or 4. heat at involved vascular site* (*with no other recognized cause); or

presence of purulent drainage/pus at the vascular site, in accordance with the CDC/NHSN Surveillance Definitions for Specific Types of Infections

For other suspected infections:
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

For confirmed infections:
laboratory-confirmed BSI based on the isolation of an organism from blood cultures; or

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.

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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	George Washington University	Washington	District of Columbia	United States	20037
2	University of Maryland at Baltimore	Baltimore	Maryland	United States	21201
3	Walter Reed National Military Medical Center	Bethesda	Maryland	United States	20889
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Oregon Health and Science University	Portland	Oregon	United States	97239
6	Houston Methodist	Houston	Texas	United States	77030