About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Renal assist device
Treatment groups
Sponsors and collaborators
3ive Labs
Lead sponsor
Fortrea
Collaborator