Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Not Applicable

Not yet recruiting

• Conditions: Renal Impairment After Cardiac Surgery; Renal Impairment; Acute Kidney Injury

• Registration Number: NCT07017933
• Lead Sponsor: 3ive Labs

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-09
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Submitted: 2025-06-15
• Last Update Posted: 2025-06-18
• Study Start: 2025-06-27
• Primary Completion: 2026-02-14
• Study Completion: 2026-04-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

To be eligible for participation in this study, an individual must meet all the following criteria:

1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery

2. Male or Female age 22 to 85 years

3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2

4. Signed and dated informed consent

5. Female patients of childbearing potential must:

   1. have negative pregnancy test at the informed consent visit,
   2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study *The only recommended contraception is condoms.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. 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
2. Pregnancy or lactation
3. Prior cardiac surgery within the last 6 months
4. Hemodynamic instability as determined by the Principal Investigator
5. Immunosuppression
6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
7. History of polycystic kidney disease
8. Patients with only one active kidney or one poorly functioning kidney
9. Evidence of current kidney obstruction (e.g., Kidney stones)
10. Evidence of current hydronephrosis
11. Active upper and/or lower urinary tract infections
12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
13. Ongoing sepsis or endocarditis
14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
15. 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
16. Unexplained/unexpected gross hematuria as determined by the Investigator
17. 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
18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator
19. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	From enrollment to post-operative day 30	The characterization and comparison of all types, frequency, and severity of adverse events (AEs) associated with JuxtaFlow treatment and controls.
Mean Peak Percent Change in Serum Creatinine	96 hours peri-operative	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.

Secondary Outcome Measures

Name	Time	Method
AUC Serum Creatinine	96 hours peri-operative	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.
AKI incidence	From post-operative day 1 to 14	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.
Creatinine Clearance	24 to 48 hours post-operatively	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.
Critical Care Length of Stay	through study study completion, an average of 1 year	The post-surgical critical care length of stay (LOS) in the United States cohort for JuxtaFlow treated subjects as compared to controls.