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

• Sponsor: 3ive Labs (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05990660
• Collaborator: SCIRENT (Other)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 7
• Patients Per Site: 5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency; Acute Kidney Injury	Device: JuxtaFlow System	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI
• Anticipated Study Start Date: Aug 4, 2023
• Anticipated Primary Completion Date: Dec 4, 2023
• Anticipated Study Completion Date: Mar 4, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. [Safety] Adverse Events Characterization [30 days]

   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.

2. [Efficacy] Creatinine Clearance [24 hours]

   The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.

3. [Efficacy] Urine Sodium Excretion [24 hours]

   The change in urine sodium excretion occurring over the treatment period of 24 hours or less.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Cardiovascular Diseases "Dedinje"	Belgrade		Serbia
2	Institute of Cardiovascular Diseases of Vojvodina	Sremska Kamenica		Serbia

Sponsors and Collaborators

• 3ive Labs
• SCIRENT

Investigators

• Principal Investigator: Slobodan Micovic, MD, Institute for Cardiovascular Diseases "Dedinje"
• Principal Investigator: Milovan Petrovic, MD, Institute of Cardiovascular Diseases of Vojvodina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3ive Labs
• ClinicalTrials.gov Identifier: NCT05990660
• Other Study ID Numbers: RAD1117-01
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by 3ive Labs: Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI); Renal Compromise; Kidney Disease; Cardiopulmonary Bypass; Renal Assist Device (RAD); Cardiac Surgery
• Additional relevant MeSH terms: Acute Kidney Injury; Renal Insufficiency

Study Results

No Results Posted as of Aug 14, 2023