Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

Detailed Description
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The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.

Official Title
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Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI

Conditions
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Renal Insufficiency, Acute Kidney Injury

Intervention / Treatment
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* Device: JuxtaFlow System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate cardiac surgical patients Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery Age 22 to 85 years eGFR < 60 mL/min/1.73m2 Signed informed consent Exclusion Criteria: End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2) Planned off-pump surgery Any patients with high-grade proteinuria (i.e., urine protein concentration > 300 mg/dL) Pregnancy Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: JuxtaFlow System<br>* Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Safety] Adverse Events Characterization | The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients. | 30 days | 
| [Efficacy] Creatinine Clearance | The change in measured creatinine clearance occurring over the treatment period of 24 hours or less. | 24 hours | 
| [Efficacy] Urine Sodium Excretion | The change in urine sodium excretion occurring over the treatment period of 24 hours or less. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI), Renal Compromise, Kidney Disease, Cardiopulmonary Bypass, Renal Assist Device (RAD), Cardiac Surgery