Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 24
- 主要终点
- Compliance rate
研究概览
简要总结
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury.
The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.
A Randomized prospective multicenter trial is needed to investigate whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing cardiac surgery. In this feasibility trial the investigators will analyze the compliance rate to the trial protocol in a multicenter, multinational cohort in preparation for a large randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
- •Urinary [TIMP-2] * [IGFBP7] >= 0.3 4h after CPB
- •Written informed consent
排除标准
- •Preexisting AKI (stage 1 and higher)
- •Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)
- •Pregnancy, breastfeeding
- •Known (Glomerulo-)-Nephritis, intersstitial nephritis or vasculitis
- •CKD with eGFR < 20 mL/min
- •Dialyses dependent CKD
- •Prior kidney transplant within the last 12 months
结局指标
主要结局
Compliance rate
时间窗: 48 hours after start of intervention
proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time
次要结局
- Free-days through of vasoactive medications and mechanical ventilation(28 days after start of intervention)
- Renal recovery(90 days after start of intervention)
- Moderate and severe AKI(72 hours after start of intervention)
- Occurence of AKI(72 hours after start of intervention)
- ICU and hospital stay(up to 1 year after start of intervention (until discharge))
- Mortality(90 days after start of intervention)
- Number of patients with renal replacement therapy(90 days after start of intervention)