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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency; Acute Kidney Injury
• Intervention / Treatment: Device: JuxtaFlow System

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Bielsko-Biata
    • Kraków, Bielsko-Biata, Poland, 43-316
      • Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii
• Serbia
  • Belgrade, Serbia
    • Institute for Cardiovascular Diseases "Dedinje"
  • Sremska Kamenica, Serbia
    • Institute of Cardiovascular Diseases of Vojvodina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: JuxtaFlow System; Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 3ive Labs
• Collaborators: SCIRENT
• Investigators: Principal Investigator: Slobodan Micovic, MD, Institute for Cardiovascular Diseases "Dedinje"; Principal Investigator: Milovan Petrovic, MD, Institute of Cardiovascular Diseases of Vojvodina

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Kidney Disease; Cardiopulmonary Bypass; Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI); Renal Compromise; Renal Assist Device (RAD)
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: RAD1117-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes