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

3ive Labs

Status: Completed

Conditions: Acute Kidney Injury; Renal Insufficiency

Treatments: Device: JuxtaFlow System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05990660

RAD1117-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Candidate cardiac surgical patients
2. Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
3. Age 22 to 85 years
4. eGFR < 60 mL/min/1.73m2
5. Signed informed consent

Exclusion criteria

1. End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2)
2. Planned off-pump surgery
3. Any patients with high-grade proteinuria (i.e., urine protein concentration > 300 mg/dL)
4. Pregnancy
5. 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
6. 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Treatment:

Device: JuxtaFlow System