RECRUITING

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Quick Facts

Study Start:2025-08-15
Study Completion:2026-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07017933

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.

Ages Eligible for Study:22 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
  2. 2. Male or Female age 22 to 85 years
  3. 3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
  4. 4. Signed and dated informed consent
  5. 5. Female patients of childbearing potential must:
  6. 1. have negative pregnancy test at the informed consent visit,
  7. 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. 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. 2. Pregnancy or lactation
  3. 3. Prior cardiac surgery within the last 6 months
  4. 4. Hemodynamic instability as determined by the Principal Investigator
  5. 5. Immunosuppression
  6. 6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
  7. 7. History of polycystic kidney disease
  8. 8. Patients with only one active kidney or one poorly functioning kidney
  9. 9. Evidence of current kidney obstruction (e.g., Kidney stones)
  10. 10. Evidence of current hydronephrosis
  11. 11. Active upper and/or lower urinary tract infections
  12. 12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
  13. 13. Ongoing sepsis or endocarditis
  14. 14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
  15. 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. 16. Unexplained/unexpected gross hematuria as determined by the Investigator
  17. 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. 18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator
  19. 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

Contacts and Locations

Study Contact

RQM+
CONTACT
412-816-8269
gradient@rqmplus.com
Alencia Washington, PhD
CONTACT
gradient@3ivelabs.com

Principal Investigator

Evelio Rodriguez, MD
PRINCIPAL_INVESTIGATOR
Ascension Healthcare

Study Locations (Sites)

Cleveland Clinic Florida
Weston, Florida, 33331
United States

Collaborators and Investigators

Sponsor: 3ive Labs

  • Evelio Rodriguez, MD, PRINCIPAL_INVESTIGATOR, Ascension Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2026-06-14

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2026-06-14

Terms related to this study

Keywords Provided by Researchers

  • renal assist device
  • RAD
  • renal impairment
  • acute kidney disease
  • JuxtaFlow

Additional Relevant MeSH Terms

  • Renal Impairment After Cardiac Surgery
  • Renal Impairment
  • Acute Kidney Injury