Kidney Protection Using the RenalGuard® System in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of AKI as defined by the RIFLE criteria
研究概览
简要总结
This is a prospective randomised control trial 1:1 in patients at risk of developing Acute Kidney Injury after cardiac surgery comparing the RenalGuard® System to current medical treatment. 110 patients will be recruited for each group. The aim of the study is to assess whether the RenalGuard® system reduces Acute Kidney Injury (AKI) after cardiac surgery as compared to current practice.
详细描述
Patients undergoing elective or in-house urgent cardiac surgery will be approached for the KIDNEY study if they fulfil the inclusion criteria. Upon consent pre-operative blood tests will be as per the usual practice. Moreover, 2ml of the serum will be stored for NGAL analysis.
Following the consenting process, patients will be randomised (envelop- based) into either having the RenalGuard® System (Study group) or current medical management (Control group).
Study group:
Patients in the study group will have the RenalGuard® System started in anaesthetic room once the peripheral line and arterial lines are sited. The RenalGuard® System will continue to run throughout the cardiac procedure in the operating room and up to 6 hours post-op after the patient has been transferred to the unit. Patients will be managed at a zero balance i.e. volume of the urine output will be matched to the volume of Hartmann's fluid infusion. Forced diuresis is then initiated.
Control group:
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
- •Patients undergoing surgery (elective or in-house urgent)
- •Patient 18 years old and over
- •Patient able to give written consent
- •Patient at risk of developing AKI after cardiac surgery (at least one factor)
- •Diabetics (IDDM or NIDDM) with normal kidney function pre-op
- •Patients with eGFR 20-60
- •Patients undergoing combined cardiac procedures when the CPB time is likely to exceed 120 minutes
- •Patients with Hb of 12.5 g/dl or below
- •Logistic Euroscore of 5 and above
- •Patient not involved with another study
排除标准
- •Emergency surgery
- •Patient unable to give written consent
- •Patient already dialysis dependent or eGFR <20
- •Patient partaking in another study
- •Pregnant patients
研究组 & 干预措施
Study group
Patients will receive the RenalGuard system
干预措施: RenalGuard (Device)
Control group
Standard practice will be performed with no RenalGuard system
结局指标
主要结局
Incidence of AKI as defined by the RIFLE criteria
时间窗: 50% rise in pre-op serum creatinine within 3 days of surgery
次要结局
未报告次要终点