Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

ConditionsRenal Impairment After Cardiac Surgery Renal Impairment Acute Kidney Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22-85

Sponsor3ive Labs

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Renal assist device
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.

Treatment groups

124 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: Renal Assist DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

From enrollment to post-operative day 30

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

through study study completion, an average of 1 year

Other outcomes

AKI severity

The severity and duration 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.

Time frame

From post-operative day 1 to 14

Urine Electrolytes

The change in urine sodium and potassium excretion rates during the treatment period (up to 72 hours) as compared to controls. Urine output will be assessed in 8-hour intervals perioperatively.

Time frame

Up to 72 hours peri-operatively

eGFR

The change in eGFR (measured by 2021 EPI Cr method) measured at baseline, perioperatively, and at 14- and 30-days post-surgery in JuxtaFlow treated subjects as compared to controls.

Time frame

From enrollment to post-operative day 30

Urine Output

The change in urine output (i.e. volume, urine flow, total oliguria time, total anuria time, etc.) over the course of treatment (up to 72 hours) as compared to controls. Urine output will be assessed in 8-hour intervals perioperatively.

Time frame

Up to 72 hours peri-operatively

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

3ive Labs

Lead sponsor

Fortrea

Collaborator

Source ClinicalTrials.gov

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