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GARNET™ Filter (GARNET Device) IDE Used in Chronic Hemodialysis Patients With a Bloodstream Infection | Clinical Trials | Clareo Health

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

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

NCT04658017•Boa Biomedical, Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Hospitalized adults (age ≥ 18 years and ≤ 90 years)
•2. Patients on chronic hemodialysis for ≥ 3 hours per treatment and a minimum of 3 times per week schedule
•3. 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:
•1\. 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:
•1. Body temperature \> 101°F (38.3°C) or \< 96.8°F (36°C);
+8 more criteria

Exclusion Criteria

•1. Pregnancy confirmed by positive urine or serum test, or lactating mothers
•2. Subject with severe concomitant disease expected to prolong hospitalization or cause death in ≤ 30 days, or terminal illness, or "do not resuscitate" code status
•3. Known sensitivity/allergy to heparin
•4. Known sensitivity/allergy to polyethersulfone dialyzers
•5. Active bleeding (e.g. active GI bleeding, hematuria or epistaxis, untreated coagulopathy or bleeding from a non-compressible site)
•6. Severe thrombocytopenia (platelet count \< 50,000/μL)
•7. 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)
•8. Inability to achieve vascular access blood flow rates of ≥250mL/min during the previous dialysis treatment
•9. Requirement for Continuous Renal Replacement Therapy/Sustained Low Efficiency Dialysis (CRRT/SLED) due to hemodynamic instability
•10. Hemodynamic instability
+9 more criteria

Locations (6)

George Washington University

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

University of Maryland at Baltimore

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Oregon Health and Science University

Portland, Oregon, United States

Houston Methodist

Houston, Texas, United States

Key Dates

Start Date

March 15, 2021

Primary Completion Date

October 15, 2021

Completion Date

December 31, 2021

Last Updated

September 5, 2021

Enrollment

ESTIMATED participants

Conditions

Bloodstream Infection

Interventions

GARNET device

DEVICE

Contacts

Nisha V Varma

CONTACT

617-963-8990 nvarma@miraki.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

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