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

Acute Kidney Injury Clinical Trial

— BIPASS-AKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05990660
• Other study ID #: RAD1117-01
• Status: Completed
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: January 18, 2024

Study information

• Verified date: January 2024
• Source: 3ive Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 18, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency

Intervention

Device:
• JuxtaFlow System
Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters

Locations

Country	Name	City	State
Poland	Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii	Kraków	Bielsko-Biata
Serbia	Institute for Cardiovascular Diseases "Dedinje"	Belgrade
Serbia	Institute of Cardiovascular Diseases of Vojvodina	Sremska Kamenica

Sponsors (2)

Lead Sponsor	Collaborator
3ive Labs	SCIRENT

Countries where clinical trial is conducted

Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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
Primary	[Efficacy] Creatinine Clearance	The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.	24 hours
Primary	[Efficacy] Urine Sodium Excretion	The change in urine sodium excretion occurring over the treatment period of 24 hours or less.	24 hours