Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Incidence and severity of AKI in both group
研究概览
简要总结
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.
详细描述
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within < 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).
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
- •"Inclusion Criteria":
- •major surgery with a duration > 4 hours plus one of the following criteria:
- •age > 75 years, or
- •sepsis, or
- •shock, or
- •polytrauma, or
- •need for invasive ventilation or catecholamines, or
- •intra-operative application of contrast-medium, or
- •preexisting chronic kidney disease (CKD1-4),
- •informed consent
排除标准
- •age < 18 years,
- •end stage renal disease (ESRD),
- •preexisting dialysis,
- •withdrawal of consent,
- •pregnancy,
- •breastfeeding
研究组 & 干预措施
standard care
Patients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines
干预措施: Ionosteril (Procedure)
interventional care
Patients in the interventional population receive - if biomarkers are elevated - individualized treatment/volume substitution (balanced electrolyte solution = Ionosteril; 1,25-5 ml/kg/bw/6 hours) ) on the basis of predefined criteria
干预措施: Ionosteril (Procedure)
结局指标
主要结局
Incidence and severity of AKI in both group
时间窗: 90 days
incidence and severity of AKI according to AKI network definition within 90 days will be monitored
次要结局
- death(90 days)
- length of ICU stay(90 days)
- length of hospital stay(90 days)
- ICU and hospital costs(90 days)
- incidence of chronic kidney disease (CKD)(90 days)
- need for renal replacement therapy,(90 days)
研究者
Tobias, Bergler, MD
PD Dr Tobias Bergler, MD
University Hospital Regensburg