NCT07017933 · 3ive Labs
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
(GRADIENT)
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
Renal assist device
The JuxtaFlow RAD includes two endoscopically placed ureteral catheters connected to a bedside pump system. The catheters are designed to deliver a mild, controlled negative pressure (-15 mmHg ± 2mmHg) into the renal pelvis of each kidney for up to 72 hours. This pressure is designed to diffuse through each of the million nephrons lowering intratubular pressure thereby improving the filtration gradient at the glomerulus while supporting overall kidney function.
Primary outcome measures
Mean Peak Percent Change in Serum Creatinine
Time frame: 96 hours peri-operative
The mean peak percent change in serum creatinine from baseline values (prior to treatment) within the first 96 hours post-surgery for JuxtaFlow treated subjects as compared to controls.
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to post-operative day 30
The characterization and comparison of all types, frequency, and severity of adverse events (AEs) associated with JuxtaFlow treatment and controls.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible for participation in this study, an individual must meet all the following criteria:
- A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
- Male or Female age 22 to 85 years
- Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
- Signed and dated informed consent
- Female patients of childbearing potential must:
- have negative pregnancy test at the informed consent visit,
- 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:
- 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
- Pregnancy or lactation
- Prior cardiac surgery within the last 6 months
- Hemodynamic instability as determined by the Principal Investigator
- Immunosuppression
- Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
- History of polycystic kidney disease
- Patients with only one active kidney or one poorly functioning kidney
- Evidence of current kidney obstruction (e.g., Kidney stones)
- Evidence of current hydronephrosis
- Active upper and/or lower urinary tract infections
- Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
- Ongoing sepsis or endocarditis
- Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
- 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
- Unexplained/unexpected gross hematuria as determined by the Investigator
- 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
- Patients who have a current unrepaired ureteral avulsion as determined by the investigator
- 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
- Weston, Florida
- Ann Arbor, Michigan
- Chapel Hill, North Carolina
- Cincinnati, Ohio
Collaborators
Fortrea
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations