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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Medicover Hospital
  Warsaw, Poland Recruiting

Study contacts

• Principal investigator: Evelio Rodriguez, MD — Ascension Healthcare
• Study coordinator: Allison Fenderson, RN, MSHS, CCRP
• Email: gradient@3ivelabs.com
• Phone: 919-744-5703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.