RECRUITING

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Description

Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and/or a certain magnitude decrease in estimated glomerular filtration rate (eGFR). The JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.

Conditions

Renal Impairment After Cardiac SurgeryRenal ImpairmentAcute Kidney Injury
Talk to us

Related Conditions:

Renal Impairment After Cardiac SurgeryRenal ImpairmentAcute Kidney Injury

Study Overview

On this page

Study Details

Study overview

Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and/or a certain magnitude decrease in estimated glomerular filtration rate (eGFR). The JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Condition
Renal Impairment After Cardiac Surgery
Intervention / Treatment

-

Contacts and Locations

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

22 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

3ive Labs,

Evelio Rodriguez, MD, PRINCIPAL_INVESTIGATOR, Ascension Healthcare

Study Record Dates

2026-06-14