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

NCT04658017 | Unknown DMC FDA Device

• 1 other identifier: 700-00002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

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.

Conditions

Bloodstream Infection

Keywords

Dialysis; Blood Stream Infection; Infection; Bloodstream; PAMPs; Hemodialysis; Sepsis

Outcome Measures

Primary Outcomes (1)

• Safety - Rate of adjudicated device- or GARNET device procedure-related Serious Adverse Events (SAEs)

  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.

  30-day follow-up post-2nd GARNET device treatment

Secondary Outcomes (2)

• Resolution of Blood Stream Infection at 30-days post 2nd GARNET device treatment

  30-day follow-up post-2nd GARNET device treatment

• 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.

Study Arms (1)

GARNET device

EXPERIMENTAL

All enrolled subjects will receive treatment with the GARNET device.

Device: GARNET device

Interventions

GARNET device DEVICE

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

GARNET device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Boa Biomedical, Inc.: lead
• Avania: collaborator

Study Sites (6)

George Washington University

Washington D.C., District of Columbia, 20037, United States

NOT YET RECRUITING

University of Maryland at Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

ACTIVE NOT RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nisha V Varma

CONTACT

617-963-8990; nvarma@miraki.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will receive treatment with the GARNET device

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 8, 2020
• Study Start: March 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: December 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)