Post-Marketing Clinical Follow Up Study to Further Assess the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- CSA-AKI incidence between study groups
研究概览
简要总结
The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC).
Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines.
For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery.
Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first.
Long-term follow up will be performed at 90 days post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and >18 years of age
- •Patient able to give written consent
- •Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:
- •coronary artery bypass graft (CABG)
- •aortic valve replacement or repair alone, with or without aortic root repair
- •mitral, tricuspid, or pulmonic valve replacement or repair
- •simultaneous replacement of several cardiac valves
- •CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- •Surgery on the aorta: aortic root and/ or ascending aorta
- •Atrial fibrillation (AF) ablation surgery if combined with other cardiac procedures.
- •Atrial septal defect (ASD) closure if combined with other cardiac procedures.
- •Excision of myxoma if combined with other cardiac procedures
- •Have at least one of the following risk factors for CSA-AKI:
- •CKD-EPI eGFR 20-59 mL/min/1.73 m²
- •Age ≥ 75 years
- •Undergoing combined surgery (e.g. CABG + Valve)
- •Logistic EuroScore of ≥5 or, Euroscore II of ≥4 or Society of Thoracic Surgeons (STS) Score ≥4
- •Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive diagnostic cardiac imaging performed within 90 days prior to surgery.
- •Insulin-requiring diabetes
- •Non-insulin-requiring diabetes with HbA1C ≥ 6.1% in the last 6 months
- •Preoperative anemia within 4 weeks of surgery
排除标准
- •Patient requiring emergency surgery
- •Surgery to be performed without CPB
- •Patient receiving furosemide at a dose>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
- •Patient who cannot be urethrally catheterize for any reason
- •Patients already dialysis dependent
- •Patients with CKD-EPI eGFR <20 mL/min/1.73 m²
- •Known or suspected AKI (KDIGO criteria) at the time of screening
- •Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days
- •Pregnant patient, self-reported
- •Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature < 28°Celsius (82.4° Fahrenheit)
- •Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission
- •Patients with pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious aetiology reported on chest x-ray or CT scan in the last 7 days
- •Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella Heart Pump, IABP) within 24 hours prior to surgery
- •Patients on extracorporeal membrane oxygenation (ECMO) or durable ventricular assist device (VAD) at the time of screening, or planned use within 24h prior to surgery
- •Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.
- •Patient underwent prior solid organ transplantation
- •Patients underwent major surgery within the last 3 months
- •Any condition which, in the judgement of the investigator, might increase the risk to the patient.
研究组 & 干预措施
Control
Standard of care
干预措施: Standard of Care (SOC) (Other)
RenalGuard Therapy
RenalGuard Therapy
干预措施: RenalGuard Therapy (Device)
结局指标
主要结局
CSA-AKI incidence between study groups
时间窗: Within 72 hours
CSA-AKI is defined as when any of the following three criteria are met: 1. An increase in serum creatinine (SCr) by ≥0.3 mg/dl (≥26.5 umol/l) within 72 hours compared to the baseline value; OR 2. An increase in SCr by ≥1.5 times from SCr value at baseline within 72 hours; OR 3. Use of Renal Replacement Therapy (RRT) within 7 days of surgery or by hospital discharge (whichever is the earliest)
次要结局
- A composite safety endpoint which includes: Significant severe clinically meaningful change in electrolytes (K+, Mg+2, Na+), New onset of postoperative atrial fibrillation, and Pulmonary edema(Within 72 hours)
- CSA-AKI Stage(Within 72 hours)
- CSA-AKI Duration(Within 7 days)
- CSA-AKI Incidence(Within 7 days)