Iohexol for Measuring Renal Function
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Prevalence of AKI in critically ill children based on iohexol plasma clearance
研究概览
简要总结
Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. AKI is associated with a worse outcome, including an increased risk of mortality compared to patients without AKI. However, this AKI prevalence estimation is based on serum creatinine based glomerular filtration rate (eGFR), which is known to be inaccurate. The investigators postulate that measured GFR (mGFR) based on iohexol clearance in critically ill children will detect a higher prevalence of children with AKI than currently used methods based on endogenous markers. This study will additionally provide mechanistic knowledge on the relative contribution of GFR and renal transport to renal function in critically ill children.
详细描述
Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.
Secondary objectives:
- To determine the prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, cystatin C and/or blood urea nitrogen based eGFR equations as well as urinary iohexol clearances.
- To determine serum Proenkephalin (PENK) levels in critically ill children.
- To compare the prevalence of AKI when this diagnosis is based on plasma iohexol clearances with the prevalence of AKI based on serum creatinine, creatinine clearance, serum cystatin C, PENK and/or Blood Urea Nitrogen (BUN) based eGFR and to assess agreement between those methods
- To determine risk factors for the development of AKI when based on iohexol clearance.
Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •0-18 years of postnatal age
- •>37 weeks of gestational age (for infants < one year postnatal age)
- •Bodyweight >2500g
- •Patients admitted to pediatric or neonatal intensive care unit
- •PELOD-II (pediatric logistic organ dysfunction score, 2nd version) of 1 or higher (= at least one failing organ)
- •Indwelling central line or arterial line in place for clinical purposes, or scheduled regular blood work for clinical reasons (at least once a day)
- •Informed written consent
排除标准
- •Known medical history of allergic reaction to injection of iodinated contrast material
- •Receiving renal replacement therapy
- •Language or cognitive inability of parents/caregivers to understand written and oral informed consent.
结局指标
主要结局
Prevalence of AKI in critically ill children based on iohexol plasma clearance
时间窗: 72 hours
AKI will be defined by using age-specific reference values of GFR. Based on their standard deviations (SD), three groups are defined: * Stage 1: mean -1 SD \> GFR \< mean -1.5 SD * Stage 2: mean -1.5 SD\> GFR \< mean -2 SD * Stage 3: GFR \< mean -2 SD Patients will be grouped according whether they lack AKI or have AKI (either stage 1, 2 or 3). When a patient will be classified as having AKI at one moment and not fulfilling the AKI-criteria at another, or classified into different stages of AKI within one day, the highest stage of the 72 hours will be used for analysis.
次要结局
- Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on CKiD Schwartz Equation (Serum Creatinine, BUN and Cytatin C)(72 hours)
- Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum cystatin C levels(72 hours)
- Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations.(72 hours)
- Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children.(72 hours)
- Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum creatinine levels(72 hours)
- Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum PENK levels(72 hours)
- Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on creatinine clearance(72 hours)
- Risk factors for the development of AKI when based on iohexol clearance.(72 hours)