Clinical trial NCT05990660: Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
Official title: Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency
Acute Kidney Injury
Keywords: Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)
Renal Compromise
Kidney Disease
Cardiopulmonary Bypass
Renal Assist Device (RAD)
Cardiac Surgery
Lead sponsor: 3ive Labs
Sponsor class: INDUSTRY
Collaborators: name: SCIRENT
First posted: 2023-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: [Safety] Adverse Events Characterization
timeFrame: 30 days
measure: [Efficacy] Creatinine Clearance
timeFrame: 24 hours
measure: [Efficacy] Urine Sodium Excretion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii
state: Bielsko-Biata
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Diseases "Dedinje"
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases of Vojvodina
Study officials:
affiliation: Institute for Cardiovascular Diseases Dedinje
name: Slobodan Micovic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Cardiovascular Diseases of Vojvodina
name: Milovan Petrovic, MD
role: PRINCIPAL_INVESTIGATOR
References: