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

Not Applicable

Completed

• Conditions: Acute Kidney Injury; Renal Insufficiency

• Registration Number: NCT05990660
• Lead Sponsor: 3ive Labs

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-14
• Study Start: 2023-09-28
• Primary Completion: 2023-12-28
• Status Verified: 2024-01
• Study Completion: 2024-01-18
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
[Safety] Adverse Events Characterization	30 days	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.
[Efficacy] Urine Sodium Excretion	24 hours	The change in urine sodium excretion occurring over the treatment period of 24 hours or less.
[Efficacy] Creatinine Clearance	24 hours	The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.

Trial Locations

Locations (3)

Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii; 🇵🇱 Kraków, Bielsko-Biata, Poland

Institute for Cardiovascular Diseases "Dedinje"; 🇷🇸 Belgrade, Serbia

Institute of Cardiovascular Diseases of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia