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Clinical trialNCT07017933RecruitingInterventional

Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Sponsor3ive LabsEnrollment124Acute Kidney InjuryRenal ImpairmentRenal Impairment After Cardiac Surgery
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Poland
  • American Heart of Poland

    Bielsko-Biala, Poland

    Krysztof Milewski, MD, PhDKrysztof Sanetra, MD
    Recruiting
  • Poznan University of Medical Sciences

    Poznan, Poland

    Active, not recruiting
  • Medicover Hospital

    Warsaw, Poland

    Krzysztof Wrobel, MD, PhD
    Recruiting
United States
  • Cleveland Clinic Florida

    Weston, Florida, United States

    Nicolas Brozzi, MD
    Recruiting
  • University of Michigan

    Ann Arbor, Michigan, United States

    Gorav Ailawadi, MDRobert Hawkins, MD
    Recruiting
  • University of North Carolina

    Chapel Hill, North Carolina, United States

    Aurelie Merlo, MD
    Recruiting
  • University of Cincinnati

    Cincinnati, Ohio, United States

    Cristiano Spadaccio, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Jul 2025
Primary completion
31 Dec 2026
Completion
14 Jun 2027
Last update posted
19 Mar 2026
Registered enrollment
124
Registry id
NCT07017933

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.