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Completed

NCT Number: NCT05990660

Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery

The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

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Key information

Conditions

Renal Insufficiency Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii, Krakow, Bielsko-Biata, Poland

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About this study

The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Candidate cardiac surgical patients
  • Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
  • Age 22 to 85 years
  • eGFR < 60 mL/min/1.73m2
  • Signed informed consent

Exclusion criteria

  • End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15 ml/min/1.73m2)
  • Planned off-pump surgery
  • Any patients with high-grade proteinuria (i.e., urine protein concentration > 300 mg/dL)
  • Pregnancy
  • 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
  • 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

Treatment and study plan

JuxtaFlow System

Device

Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters

Primary outcomes

  1. [Safety] Adverse Events Characterization

    Time frame: 30 days

    The characterization of all type, frequency, severity, and device-relatedness of the adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System for the treatment of renal insufficiency in cardiac surgery patients.

  2. [Efficacy] Creatinine Clearance

    Time frame: 24 hours

    The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.

  3. [Efficacy] Urine Sodium Excretion

    Time frame: 24 hours

    The change in urine sodium excretion occurring over the treatment period of 24 hours or less.

Sponsors and collaborators

Lead sponsor

3ive Labs

Industry

Collaborators

  • SCIRENT

Registry information

Official study title

Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI

Acronym: BIPASS-AKI

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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