Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
GRADIENT
1 other identifier
interventional
124
2 countries
7
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedStudy Start
First participant enrolled
July 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 14, 2027
March 19, 2026
July 1, 2025
1.5 years
May 9, 2025
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
From enrollment to post-operative day 30
Secondary Outcomes (4)
AUC Serum Creatinine
96 hours peri-operative
Creatinine Clearance
24 to 48 hours post-operatively
AKI incidence
From post-operative day 1 to 14
Critical Care Length of Stay
through study study completion, an average of 1 year
Other Outcomes (11)
AKI severity
From post-operative day 1 to 14
Urine Electrolytes
Up to 72 hours peri-operatively
eGFR
From enrollment to post-operative day 30
- +8 more other outcomes
Study Arms (2)
Standard of Care
NO INTERVENTIONA 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
EXPERIMENTALSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cleveland Clinic Florida
Weston, Florida, 33331, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
American Heart of Poland
Bielsko-Biala, 43-316, Poland
Poznan University of Medical Sciences
Poznan, 60-354, Poland
Medicover Hospital
Warsaw, 02-972, Poland
Related Publications (2)
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.
BACKGROUNDRao 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.
PMID: 34405731BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evelio Rodriguez, MD
Ascension Healthcare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2025
First Posted
June 12, 2025
Study Start
July 16, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
June 14, 2027
Last Updated
March 19, 2026
Record last verified: 2025-07