Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
Florida
Cleveland Clinic Florida
RECRUITING
Weston
Contact Information
Primary
RQM+
gradient@rqmplus.com
412-816-8269
Backup
Alencia Washington, PhD
gradient@3ivelabs.com
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2026-06-14
Participants
Target number of participants: 124
Treatments
No_intervention: Standard of Care
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.
Experimental: Renal Assist Device
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.
Related Therapeutic Areas
Sponsors
Leads: 3ive Labs
Collaborators: RQM+

This content was sourced from clinicaltrials.gov

Similar Clinical Trials