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

NCT ID: NCT05990660

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-28
• Study Completion Date: 2024-01-18

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.

Conditions

Renal Insufficiency; Acute Kidney Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

JuxtaFlow System

Intervention Type: DEVICE

Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters

Interventions

JuxtaFlow System

Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SCIRENT

UNKNOWN

Sponsor Role: collaborator

3ive Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Slobodan Micovic, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Cardiovascular Diseases Dedinje

Milovan Petrovic, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Cardiovascular Diseases of Vojvodina

Locations

Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii

Krakow, Bielsko-Biata, Poland

Institute for Cardiovascular Diseases "Dedinje"

Belgrade, , Serbia

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, , Serbia

Countries

Poland; Serbia

Other Identifiers

RAD1117-01

Identifier Type: -

Identifier Source: org_study_id