NCT02561247终止不适用
Clinical Evaluation of the Prismaflex HF20 Set and Prismaflex® System 7.10 for Acute CRRT in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 12
- 主要终点
- Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury (AKI) in pediatric patients by reducing blood urea nitrogen (BUN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a hospital admission body weight ≥8 and <20 kg (ie, ≥17.6 and <44.09 lbs).
- •Patients with AKI defined as either 1) AKI by the Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury Guideline serum creatinine criteria, which is a >50% rise in serum creatinine over baseline or a 0.3 mg/dL SCr rise in 48 hours OR 2) as AKI by the Pediatric modified Risk, Injury, Failure, Loss, End-Stage Renal Disease (pRIFLE) criteria which is a 25% reduction in estimated creatinine clearance,16 OR 3) a serum creatinine >1.2 mg/dL. OR Patients with severe fluid overload, defined as a >10% fluid accumulation relative to the ICU admission.
- •Patients who have received RRT previously can be included in the study if >24 hours have elapsed since their previous RRT treatment.
- •Provide written informed consent from one or both parents, as required by the local IRB or legal guardians, unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child per 21 CFR Part 50.55(e).
排除标准
- •Patients a) weighing 8.0-20.0 kg with a hemoglobin of <7.0 g/dL, b) weighing 8.0-12.0 kg with a hemoglobin of <8.0 g/dL (unless blood prime used), and c) weighing 12.1-20.0 kg with a hemoglobin of <7.5 g/dL (unless blood prime used).
- •Children who are wards of the state.
结局指标
主要结局
Percent Change From Baseline in BUN (mg/dL) at 24 Hours Following Initiation of CRRT
时间窗: 24 hours from CRRT initiation
Blood Urea Nitrogen (BUN)
次要结局
- Percent Change From Baseline in Creatinine (Umol/L) at 24 Hours Following Initiation of CRRT(24 hours from CRRT initiation)
- HF20 Set Filter Survival Time(Up to 72 Hours after Initiation)
- Percent Change From Baseline in Bicarbonate (mmol/L) at 24 Hours Following Initiation of CRRT(24 hours from CRRT initiation)
研究者
研究点 (12)
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