Renal Impairment After Cardiac SurgeryGRADIENTNCT07017933
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
A study testing Renal assist device in people with Renal Impairment After Cardiac Surgery and Renal Impairment, run by 3ive Labs at 7 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Renal Impairment After Cardiac Surgery, Renal Impairment, Acute Kidney Injury
- What is being tested?
- Renal assist device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 16 Jul 2025to 14 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Alencia Washington, PhD contact
7 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
China Green, (734) 764-5500, chjgreen@med.umich.edu
Amanda Kaperek
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27514
Michelle Becton, 919-843-2698, michelle_becton@med.unc.edu
Karen Van Manen, karen_vanmanen@med.unc.edu
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Devin M Wakefield, MSc, CCRC, 513-558-7247, wakefidm@ucmail.uc.edu
Dina Gomaa, gomaada@ucmail.uc.edu
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Rene Aleman, MD, 866-293-7866, alemanr2@ccf.org
Jennifer Ballas, 866-293-7866, ballasj2@ccf.org
Poland3 sites, 2 recruiting
- Recruiting
American Heart of Poland
Bielsko-Biala, 43-316
Monica Filary, +48 33 472 63 00, clinicaltrials@ahop.pl
Aleksandra Zygmunt, aleksandra.zygmunt@ahop.pl
- Active, not recruiting
Poznan University of Medical Sciences
Poznan, 60-354
- Recruiting
Medicover Hospital
Warsaw, 02-972
Magdalena Fabijanska, +48 519532444, hospital_clinical_trials@medicover.pl
Krzysztof Wrobel, MD, PhD
About this study
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.
- Being tested
- Renal assist device
- Keywords
- renal assist device, RAD, renal impairment, acute kidney disease, JuxtaFlow
- Medical subject headings
- Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal assist deviceDevice
Also called RAD, JuxtaFlow
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | A standard bladder catheter (i.e. Foley) will be placed for bladder urine collection peri-operatively for up to 72 hours while in critical care. No JuxtaFlow catheters will be placed in control subjects. |
| Renal Assist Device | Experimental | Subjects randomized to the Treatment group will receive up to 72 hours of controlled negative pressure (-15mmHg) into the renal pelvis of each kidney. Treatment will be discontinued when the subject is transferred out of critical care after at least 24 hours of treatment. A standard bladder catheter (i.e. Foley) will also be placed for bladder urine collection peri-operatively for up to 72 hours. Receives: Device: Renal assist device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Percent Change in Serum Creatinine
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.
Measured: 96 hours peri-operative
Incidence of Treatment-Emergent Adverse Events
The characterization and comparison of all types, frequency, and severity of adverse events (AEs) associated with JuxtaFlow treatment and controls.
Measured: From enrollment to post-operative day 30
Secondary outcomes (4)
AUC Serum Creatinine
The area under the curve of serum creatinine changes from baseline values (prior to treatment) up to 96 hours post-surgery for JuxtaFlow treated subjects as compared to controls.
Measured: 96 hours peri-operative
Creatinine Clearance
The average creatinine clearance as a measure of acute glomerular filtration rate, assessed for a minimum of 24 and up to 48 hours in 8-hour intervals during postoperative ICU JuxtaFlow treatment as compared to controls.
Measured: 24 to 48 hours post-operatively
AKI incidence
The incidence of acute kidney injury (as determined by the KDIGO criteria) during post-surgical hospitalization and 14 days post-surgery with treatment as compared to controls.
Measured: From post-operative day 1 to 14
Critical Care Length of Stay
The post-surgical critical care length of stay (LOS) in the United States cohort for JuxtaFlow treated subjects as compared to controls.
Measured: through study study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start16 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Impairment After Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3ive Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
- Investigators
- Evelio Rodriguez, MD, Principal investigator, Ascension Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017933
- Sponsor's protocol ID
- GRADIENT 20-10
- Acronym
- GRADIENT
- Status last verified
- Jul 2025
- First submitted
- 9 May 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rodriguez E, Petrovic M, Milewski K, et al. Feasibility Study of Renal Negative Pressure Treatment after Cardiac Surgery with Cardiopulmonary Bypass. Ann Thorac Surg Short Rep. 2026 Feb 25. doi: [DOI]. Epub ahead of print.
Rao VS, Maulion C, Asher JL, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, Mahoney D, Turner JM, Wilson FP, Wilcox CS, Testani JM. Renal negative pressure treatment as a novel therapy for heart failure-induced renal dysfunction. Am J Physiol Regul Integr Comp Physiol. 2021 Oct 1;321(4):R588-R594. doi: 10.1152/ajpregu.00115.2021. Epub 2021 Aug 18.
PubMed 34405731