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Bloodstream InfectionNCT04658017

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

A study testing GARNET device in people with Bloodstream Infection, run by Boa Biomedical, Inc. at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Bloodstream Infection
What is being tested?
GARNET device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
15 Mar 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 1. fever (>38.0°C), 2. pain, 3. erythema, or 4. heat at involved vascular site (with no other recognized cause); or
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  • 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.
  • 4. Subject agrees to comply with all follow-up evaluations
  • 5. 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

6 sites in 1 country.

Nisha V Varma contact

617-963-8990 ext. 6260

nvarma@miraki.com

6 sites in 1 country

United States6 sites, 5 recruiting

  • University of Maryland at Baltimore

    Baltimore, Maryland, 21201

    Matthew R Weir, MD

    Matthew R Weir, MD

    Recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

    Active, not recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Alon Dagan, MD

    Alon Dagan, MD

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Horacio E Adrogue, MD, FASN

    Horacio E Adrogue, MD, FASN

    Not yet recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Akram Khan, MD

    Akram Khan, MD

    Recruiting

  • George Washington University

    Washington D.C., District of Columbia, 20037

    Dominic Raj, MD

    Dominic Raj, MD

    Not yet recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
GARNET device
Keywords
Dialysis, Blood Stream Infection, Infection, Bloodstream, PAMPs, Hemodialysis, Sepsis
Medical subject headings
Sepsis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GARNET deviceDevice

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

Study groups in NCT04658017
Study groupRoleWhat they receive
GARNET deviceExperimentalAll enrolled subjects will receive treatment with the GARNET device.
Receives: Device: GARNET device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

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

    • Resolution of Blood Stream Infection

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

  2. 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.

    • Extent of clearance of solutes (small and middle molecules)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start15 Mar 2021
  3. Primary completion15 Oct 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All enrolled subjects will receive treatment with the GARNET device
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04658017
Sponsor's protocol ID
700-00002
Status last verified
Sep 2021
First submitted
19 Nov 2020
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Individual participant data will not be made available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing GARNET device in people with Bloodstream Infection, run by Boa Biomedical, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nisha V Varma (617-963-8990 ext. 6260, nvarma@miraki.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Rate of adjudicated device- or GARNET device procedure-related Serious Adverse Events (SAEs) (time frame: 30-day follow-up post-2nd GARNET device treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04658017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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