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Study of JuxtaFlow Renal Assist Device for Kidney Protection During Cardiac Surgery

This study is investigating a device called the JuxtaFlow Renal Assist Device (RAD) for patients undergoing certain heart surgeries. If you have kidney problems (renal impairment) and are having coronary artery bypass grafting (CABG) or valvular surgery, you might be at higher risk for worsening kidney function after surgery. The JuxtaFlow RAD uses small tubes placed in your kidneys to apply gentle pressure, aiming to help your kidneys work better during and after surgery. Researchers will measure changes in a kidney function marker called serum creatinine and track any side effects. To join, you need to be between 22 and 85 years old and have an estimated glomerular filtration rate (eGFR) between 15 and 60 mL/min/1.73m2. The study plans to enroll 124 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 124 participants.
What's involved
The JuxtaFlow RAD will be used for up to 72 hours. Researchers will monitor for side effects from enrollment until 30 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events until 30 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07017933

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Recruiting
NAAges 22–85InterventionalPrevention
3ive Labs
~124 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Renal assist device

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Peak Percent Change in Serum Creatinine
Measured over 96 hours peri-operative
+1 more outcome measured

Conditions

Renal Impairment After Cardiac Surgery
Renal Impairment
Acute Kidney Injury

Explore related trials

Acute Renal FailureRenal Impairment

Where it's being run

7 sites across 5 states
Poland3
Florida1
Michigan1
North Carolina1
Ohio1

Study leadership

  • Evelio Rodriguez, MD · PRINCIPAL_INVESTIGATOR · Ascension Healthcare

Who to contact

Allison Fenderson, RN, MSHS, CCRP
[email protected]
919-744-5703
Email the study team

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What this trial measures

  • Mean Peak Percent Change in Serum Creatinine96 hours peri-operative

    The mean peak percent change in serum creatinine from baseline values (prior to treatment) within the first 96 hours post-surgery for JuxtaFlow treated subjects as compared to controls.

  • Incidence of Treatment-Emergent Adverse EventsFrom enrollment to post-operative day 30

    The characterization and comparison of all types, frequency, and severity of adverse events (AEs) associated with JuxtaFlow treatment and controls.