Assessment of Worldwide AKI in Pediatrics, Renal Angina and Epidemiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,237
- 试验地点
- 32
- 主要终点
- Severe AKI in first seven days of ICU Admission
研究概览
简要总结
Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in children is limited by single center retrospective data and inconsistent diagnostic and stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a composite of early injury signs and risk of disease, will predict severe subsequent AKI in critically ill children and 2) the incorporation of urinary biomarkers into the renal angina scoring system will improve the prediction of the severe injury. The AWARE study is conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry will create the largest ever repository of information available on AKI in children.
详细描述
The AWARE study is a multicenter prospective observational study designed to achieve the following three goals:
- Establish the first international pediatric AKI registry to describe in detail the epidemiology and outcome of AKI in different pediatric and cardiac ICUs around the world.
- Validate the precision of RAI in ruling out AKI in a large, heterogeneous study population.
- Evaluate the predictive value of using RAI before and after the incorporation of four different urinary AKI biomarkers used in different combinations.
To achieve these primary goals, children admitted to PICUs and/or pediatric cardiac ICUs from different US and international centers will be screened for enrollment eligibility. Patients admitted to general PICU and non-surgical patients admitted to cardiac ICUs are considered the target population of AWARE. Patients admitted to neonatal ICUs and post-surgical admissions to cardiac ICUs are not included in AWARE. Both clinical variables and urinary biomarkers would be needed to accomplish the analysis.
A- Clinical variables: Clinical data of interest at study entry will include age, gender, race, ethnicity, height, weight, date of ICU admission, date of ICU discharge, date of hospital discharge, admission diagnosis(es) and primary co-morbidities. Creatinine clearance (eCrCl) will be estimated by the modified Schwartz formula29. Baseline creatinine will be collected if the patient had a listed value in the medical record in the 90 days prior to admission, with the lowest value selected if multiple measurements are present. In cases where no baseline data is available, reference eCrCl will be estimated as 120 mL/min/1.73m2. 30
Clinical data will be recorded on admission and on a daily basis for the first seven days of the PICU admission or till discharge from the PICU whatever is earlier. Another set of data will be collected to evaluate the primary and secondary outcomes of the study (see later). The outcomes data will be collected on day 28 after ICU admission when available or by most recent available data before hospital discharge for patients with no available data on day 28.
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
- 3 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 90 days
- •Age less than 25 years
排除标准
- •Patients on maintenance hemodialysis, peritoneal dialysis, or with chronic kidney disease with a baseline eGFR of <15 mL/min/1.73m2
- •Patients with renal transplant received less than 90 days from the ICU admission.
- •Patients admitted to ICU immediately post-operative to within three months following surgical correction of congenital heart disease.
- •Patients with uncorrected congenital heart disease. This criteria does not include patients with isolated uncorrected ventricular septal defect (VSD), atrial septal defect (ASD), patent ductus arteriosus (PDA) and patent foramen ovale (PFO).
- •Patients following cardiac catheterization.
结局指标
主要结局
Severe AKI in first seven days of ICU Admission
时间窗: Within 7 Days of ICU admission
AKI as defined by KDIGO stage 2 or 3 (by either changes in creatinine or UOP) assessed within 7 days of ICU admission
次要结局
- Determination of AKI Progression(7 days)
- AKI Conferred Risk on Mortality(28 days)
- Identification of Predictors of Severe AKI(7 days)
- Comparison of AKI by Creatinine and Urine Output(7 and 28 days)
研究者
Stuart Goldstein, MD
Co-Director, Center for Acute Care Nephrology
Children's Hospital Medical Center, Cincinnati