Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Conditions

• Acute Kidney Injury
• Renal Impairment
• Renal Impairment After Cardiac Surgery

Eligibility Criteria

Sex

ALL

Age

22 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Renal assist device — 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.

Study Details

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.

Key Dates

Start date

Jul 16, 2025

Status verified

Jul 2025

Primary completion

Dec 31, 2026

Completion

Jun 14, 2027

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: Standard of Care
  A standard bladder catheter (i.e. Foley) will be placed for bladder urine collection peri-operatively for up to 72 hours while in critical care. No JuxtaFlow catheters will be placed in control subjects.
• Experimental: Renal Assist Device
  Subjects randomized to the Treatment group will receive up to 72 hours of controlled negative pressure (-15mmHg) into the renal pelvis of each kidney. Treatment will be discontinued when the subject is transferred out of critical care after at least 24 hours of treatment. A standard bladder catheter (i.e. Foley) will also be placed for bladder urine collection peri-operatively for up to 72 hours.

Primary Outcome Measure

Mean Peak Percent Change in Serum Creatinine [ Time Frame: 96 hours peri-operative ]

Central Contacts

• Allison Fenderson, RN, MSHS, CCRP
  919-744-5703
  [email protected]
• Alencia Washington, PhD
  [email protected]

Locations (4)

Find similar trials in Weston, FL

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