Status:
COMPLETED
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
Lead Sponsor:
3ive Labs
Collaborating Sponsors:
SCIRENT
Conditions:
Renal Insufficiency
Acute Kidney Injury
Eligibility:
All Genders
22-85 years
Phase:
NA
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 pa...
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....
Eligibility Criteria
Inclusion
- Candidate cardiac surgical patients
- Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
- Age 22 to 85 years
- eGFR \< 60 mL/min/1.73m2
- Signed informed consent
Exclusion
- End-stage renal disease (receiving hemodialysis or glomerular filtration rate \<15 ml/min/1.73m2)
- Planned off-pump surgery
- Any patients with high-grade proteinuria (i.e., urine protein concentration \> 300 mg/dL)
- Pregnancy
- 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
- 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
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05990660
Start Date
September 28 2023
End Date
January 18 2024
Last Update
January 23 2024
Active Locations (3)
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1
Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii
Krakow, Bielsko-Biata, Poland, 43-316
2
Institute for Cardiovascular Diseases "Dedinje"
Belgrade, Serbia
3
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia