Study of JuxtaFlow Renal Assist Device to Protect Kidney Function During Cardiac Surgery For Adults Aged 22 to 85 with Kidney Impairment

What this Trial Is About

Patients with renal insufficiency undergoing cardiac surgery with cardiopulmonary bypass CPB face a high risk of worsening kidney function after surgery, which can lead to longer stays in intensive care, additional health problems, and increased risk of death within 30 days. Kidney problems are usually identified by changes in blood tests measuring kidney filtration. The JuxtaFlow Renal Assist Device RAD is being studied to help maintain or improve kidney filtration during surgery by applying controlled negative pressure to the kidneys collecting system, aiming to support kidney function during the stress of surgery and reduce complications. The study compares two groups one receiving standard care with a bladder catheter for urine collection, and another group receiving treatment with the JuxtaFlow RAD device. This device uses two ureteral catheters connected to a pump that applies mild negative pressure to each kidney for up to 72 hours, starting during surgery and continuing while the patient is in critical care. Treatment stops once the patient leaves critical care after at least 24 hours, and all patients have a bladder catheter for urine monitoring during this period. Participants will be monitored with blood tests measuring kidney function, including serum creatinine levels and creatinine clearance, during and after surgery for up to 96 hours. Researchers will also track any adverse events related to treatment up to 30 days, as well as kidney injury incidence and length of stay in critical care over about one year. This study aims to understand how the device affects kidney health during and after cardiac surgery and to monitor safety and recovery in detail.

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes