Renal assist device to protect kidney function during on-pump heart surgery

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

This study will try a temporary Renal Assist Device during on-pump coronary artery bypass or valve surgery to help adults with weakened kidneys (eGFR 15–60) keep kidney function after the operation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 22 Years to 85 Years
• Sex: All
• Sponsor: 3ive Labs (Industry-sponsored)
• Locations: 7 sites (Weston, Florida and 6 other locations)
• Trial ID: NCT07017933 on ClinicalTrials.gov

What this trial studies

The trial uses the JuxtaFlow® Renal Assist Device, which applies a mild controlled negative pressure to the renal pelvis during the perioperative period to increase effective filtration pressure and reduce tubular pressure. The device is used in patients with preexisting renal impairment who are undergoing elective or urgent on‑pump CABG and/or valvular surgery. Participating sites include several U.S. academic centers, and enrolled adults are aged 22–85 with eGFR 15–60 mL/min/1.73m2. Outcomes of interest include preservation of renal function, ICU length of stay, surgical complications, and short‑term mortality following surgery.

Who should consider this trial

Good fit: Adults aged 22–85 scheduled for elective or urgent on‑pump CABG and/or valve surgery with an eGFR of 15–60 mL/min/1.73m2 and who can give informed consent are ideal candidates.

Not a fit: Patients with normal kidney function (eGFR >60), those not undergoing on‑pump cardiac surgery, or anyone unable to provide informed consent are unlikely to gain benefit from this device.

Why it matters

Potential benefit: If successful, the device could reduce worsening kidney injury after cardiac surgery, shorten ICU stays, and lower postoperative complications and 30‑day mortality.

How similar studies have performed: Preclinical work and limited early human experience support the physiological concept of reducing intrarenal pressure, but this specific Renal Assist Device represents a relatively novel clinical approach with limited prior outcome data.

Eligibility criteria

Inclusion Criteria:

To be eligible for participation in this study, an individual must meet all the following criteria:

1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
2. Male or Female age 22 to 85 years
3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
4. Signed and dated informed consent
5. Female patients of childbearing potential must:

   1. have negative pregnancy test at the informed consent visit,
   2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \*The only recommended contraception is condoms.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent
2. Pregnancy or lactation
3. Prior cardiac surgery within the last 6 months
4. Hemodynamic instability as determined by the Principal Investigator
5. Immunosuppression
6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
7. History of polycystic kidney disease
8. Patients with only one active kidney or one poorly functioning kidney
9. Evidence of current kidney obstruction (e.g., Kidney stones)
10. Evidence of current hydronephrosis
11. Active upper and/or lower urinary tract infections
12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
13. Ongoing sepsis or endocarditis
14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
15. 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; or severe BPH
16. Unexplained/unexpected gross hematuria as determined by the Investigator
17. 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
18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator
19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures

Where this trial is running

Weston, Florida and 6 other locations

• Cleveland Clinic Florida — Weston, Florida, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
• University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
• American Heart of Poland — Bielsko-Biala, Poland (Recruiting)
• Poznan University of Medical Sciences — Poznan, Poland (Active_not_recruiting)
• Medicover Hospital — Warsaw, Poland (Recruiting)

Study contacts

• Principal investigator: Evelio Rodriguez, MD — Ascension Healthcare
• Study coordinator: Allison Fenderson, RN, MSHS, CCRP

Conditions Renal Impairment After Cardiac Surgery; Renal Impairment; Acute Kidney Injury; renal assist device; RAD; renal impairment; acute kidney disease; JuxtaFlow