Renal negative pressure treatment as a novel therapy for heart failure-induced renal dysfunction.
Veena S Rao, Christopher Maulion, Jennifer L Asher...
https://pubmed.ncbi.nlm.nih.gov/34405731Actively Recruiting
Phase Not Applicable
Age: 22Years - 85Years
All Genders
ID07017933
Groundbreaking Renal Assist Device Intervening to Enhance CardioThoracic Surgery Outcomes
Led by 3ive Labs · Updated on 2026-03-19
124
Participants Needed
7
Research Sites
23 weeks
Total Duration
On this page
Sponsors
3
3ive Labs
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients with renal insufficiency undergoing cardiac surgery with cardiopulmonary bypass (CPB) face a high risk of worsening kidney function after surgery, which can lead to longer stays in intensive care, additional health problems, and increased risk of death within 30 days. Kidney problems are usually identified by changes in blood tests measuring kidney filtration. The JuxtaFlow Renal Assist Device (RAD) is being studied to help maintain or improve kidney filtration during surgery by applying controlled negative pressure to the kidney's collecting system, aiming to support kidney function during the stress of surgery and reduce complications. The study compares two groups: one receiving standard care with a bladder catheter for urine collection, and another group receiving treatment with the JuxtaFlow RAD device. This device uses two ureteral catheters connected to a pump that applies mild negative pressure to each kidney for up to 72 hours, starting during surgery and continuing while the patient is in critical care. Treatment stops once the patient leaves critical care after at least 24 hours, and all patients have a bladder catheter for urine monitoring during this period. Participants will be monitored with blood tests measuring kidney function, including serum creatinine levels and creatinine clearance, during and after surgery for up to 96 hours. Researchers will also track any adverse events related to treatment up to 30 days, as well as kidney injury incidence and length of stay in critical care over about one year. This study aims to understand how the device affects kidney health during and after cardiac surgery and to monitor safety and recovery in detail.
CONDITIONS
Brief Title
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
Who Can Participate
Age: 22Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
- Male or female aged 22 to 85 years
- Estimated glomerular filtration rate (eGFR) between 15 and 60 mL/min/1.73m2
- Signed and dated informed consent
- Female patients of childbearing potential must have a negative pregnancy test at consent and use approved contraception (condoms) during the study
You will not qualify if you...
- Unable to understand study risks or give informed consent
- Pregnant or breastfeeding
- Prior cardiac surgery within the last 6 months
- Hemodynamic instability
- Immunosuppression
- Active infections such as HIV, tuberculosis, or hepatitis
- History of polycystic kidney disease
- Only one active or poorly functioning kidney
- Current kidney obstruction or kidney stones
- Current hydronephrosis
- Active urinary tract infections
- Malignancy or cancer surgery within 5 years or ongoing cancer treatment
- Ongoing sepsis or endocarditis
- Expected 30-day postoperative mortality over 10%
- Conditions increasing risk or preventing study compliance, including urinary organ injuries or severe benign prostatic hyperplasia
- Unexplained gross hematuria
- Current or planned treatment with another investigational drug or device within 3 months
- Current unrepaired ureteral avulsion
- Contraindications for urological interventions or study procedures involving ureteral catheterization or cystoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Surgery and Immediate Post-operative Care
Duration - Up to 72 hours
Participants undergo coronary artery bypass grafting (CABG) and/or valvular surgery. Those randomized to the treatment group receive up to 72 hours of controlled negative pressure delivered to each kidney via ureteral catheters. All participants have a standard bladder catheter placed for urine collection during this period.
Peri-operative care in critical care setting with continuous monitoring
Post-operative Follow-up
Duration - Up to 30 days for adverse event monitoring; up to 1 year for critical care length of stay assessment
Participants are monitored for kidney function, treatment-emergent adverse events, and recovery outcomes including serum creatinine and critical care length of stay.
Visits and assessments at multiple timepoints including post-operative days 1 to 14 and up to 1 year
Trial Site Locations
Total: 7 locations
1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
4
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
5
American Heart of Poland
Bielsko-Biala, Poland, 43-316
Actively Recruiting
6
Poznan University of Medical Sciences
Poznan, Poland, 60-354
Active, Not Recruiting
7
Medicover Hospital
Warsaw, Poland, 02-972
Actively Recruiting
Loading map...
Research Team
A
Allison Fenderson, RN, MSHS, CCRP
A
Alencia Washington, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here