European Registry of Dialysis Treatment of Pediatric Acute Kidney Injury (AKI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,892
- 试验地点
- 1
- 主要终点
- incidence of AKI requiring dialysis in PICU and non-PICU children
研究概览
简要总结
Acute kidney injury (AKI) is a frequent clinical condition in hospitalized, in particular, in critically ill children. Moreover, AKI is an independent predictor of mortality. An incidence of AKI in pediatric intensive care units (PICU) between 10 and 62% has been reported in recent clinical trials adopting pRIFLE or AKIN criteria, with the highest risk present in cardiac surgery patients. Despite significant developments in the management of AKI, the overall mortality rate of patients with AKI has not improved significantly. Currently, there is no consensus concerning the optimum dialysis modalities to adopt in pediatric AKI. No studies have prospectively compared the efficacy of different types of RRT for pediatric AKI. While PD remains the most commonly used modality in children worldwide, over the last decade CRRT has become the preferred treatment modality for critically ill children with AKI in North America.
The investigators have recently conducted a survey among 34 European Pediatric Nephrology Centers in the ESCAPE Network to obtain current information on dialysis management practices in children. Approximately 900 children with AKI requiring dialysis are managed at these 34 centers per year. This number supports the creation of a prospective European AKI registry.
详细描述
The main scope of the Registry is to report the epidemiology and outcome of children with AKI treated with dialysis in over 30 Pediatric Nephrology Centers in Europe. Secondary aims are to verify the association of a specific dialysis modality with the outcome and the association of primary disease, co-morbidities, nephrotoxic agents, fluid overload, anuria, basic hemodynamic parameters (BP, HR), basic nutritional intakes (protein and calorie supply) with the outcome.
Data capture will be exclusively web-based via electronic case report forms. Every participating site will be provided with a unique code and password that identify the corresponding site.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with AKI at Hospital admission or who developed AKI during hospitalization treated with dialysis (PD, HD, CRRT)
- •Age: 0-18 yrs
排除标准
- •Children with known preexisting CKD (i.e.: AKI on CKD)
结局指标
主要结局
incidence of AKI requiring dialysis in PICU and non-PICU children
时间窗: 3 years
urine output and serum creatinine
次要结局
- difference in mortality related to dialysis modality(3 years)
- difference in the primary outcome related to SpO2(3 years)
- difference in the primary outcome related to severity score(3 years)
- difference in the primary outcome related to Mean Airway Pressure(3 years)
- difference in the primary outcome related to paO2(3 years)
- Mortality rates(3 years)
- difference in the primary outcome related to duration of mechanical ventilation(3 years)
- difference in the primary outcome related to FiO2(3 years)
研究者
Mariella Enoc
Principal Investigator
Bambino Gesù Hospital and Research Institute