RecruitingNot ApplicableNCT07017933

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes


Sponsor

3ive Labs

Enrollment

124 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and/or a certain magnitude decrease in estimated glomerular filtration rate (eGFR). The JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.


Eligibility

Min Age: 22 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Renal assist device for people with acute kidney injury, renal impairment, and other related conditions. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERenal assist device

The JuxtaFlow RAD includes two endoscopically placed ureteral catheters connected to a bedside pump system. The catheters are designed to deliver a mild, controlled negative pressure (-15 mmHg ± 2mmHg) into the renal pelvis of each kidney for up to 72 hours. This pressure is designed to diffuse through each of the million nephrons lowering intratubular pressure thereby improving the filtration gradient at the glomerulus while supporting overall kidney function.


Locations(7)

Cleveland Clinic Florida

Weston, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

American Heart of Poland

Bielsko-Biala, Poland

Poznan University of Medical Sciences

Poznan, Poland

Medicover Hospital

Warsaw, Poland

View Full Details on ClinicalTrials.gov

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NCT07017933


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