Bypass Surgery Incorporating a Negative Pressure Renal Assist Device to Resolve AKI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 3ive Labs
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- [Safety] Adverse Events Characterization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
结局指标
主要结局
[Safety] Adverse Events Characterization
时间窗: 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.
[Efficacy] Urine Sodium Excretion
时间窗: 24 hours
The change in urine sodium excretion occurring over the treatment period of 24 hours or less.
[Efficacy] Creatinine Clearance
时间窗: 24 hours
The change in measured creatinine clearance occurring over the treatment period of 24 hours or less.
次要结局
未报告次要终点