Predicting Acute Kidney Injury in Infants Exposed to Nephrotoxic Drugs: A Big Data Approach to Predict NEOnatal Acute Kidney Injury in Newborns expoSed to nephroTOxic Drugs. (NeoAKI STOP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,200
- 试验地点
- 1
- 主要终点
- Develop a model that can predict the occurrence of AKI in infants admitted to the NICU;
研究概览
简要总结
This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach.
The main question it aims to answer are:
- Develop a model that can predict the occurrence of AKI in infants admitted to the NICU;
- Identify the drug or combination of drugs associated with an increased risk of AKI.
The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.
详细描述
- Rationale and background Acute Kidney Injury (AKI) is defined as the sudden impairment of kidney function that results in altered hydro electrolyte balance and renal waste product elimination.
Extensive evidence shows that the onset of AKI in critically ill pediatric patients is associated with an increased risk of death and a longer length of hospitalization. Furthermore, in patients who survive an episode of AKI, there is an increased risk of developing long-term morbidity, particularly Chronic Kidney Disease (CKD).
The neonatal kidney has numerous features on the pathophysiological level that predispose this population more to AKI than at other life ages.
In addition to the peculiarities related to the development and physiology of the kidney, especially if preterm, infants admitted to the NICU are exposed to multiple risk factors that may contribute to the onset of AKI.
A recent multicenter study conducted in neonatal intensive care units in Canada, Australia, India, and the United States reported an overall incidence of AKI of 29.9% and showed that the development of AKI is an independent risk factor for death and prolonged hospitalization. The incidence of AKI by gestational age also showed a typical U-shaped distribution, with the greater occurrence at the two extremes represented by infants with gestational ages >36 weeks (36.7%) and <29 weeks (47.9%), while the lowest value was recorded in the 29-36 weeks range.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born between 01/01/2010 and 31/12/2022;
- •admitted within 24 hours of birth in the NICU (both inborn and outborn);
- •availability of at least two serum creatinine values or a daily hourly diuresis assessment in the first 30 days of life.
排除标准
- •pre- or postnatal diagnosis of severe urologic and/or nephrologic pathology on a malformative and/or genetic basis;
- •finding of serum creatinine > 2 mg/dl in the first 24 hours of life;
- •genetic conditions that may impact patient survival or renal function;
- •length of stay in the NICU less than 48 hours (death or transfer to another department);
- •infants undergoing ECMO.
结局指标
主要结局
Develop a model that can predict the occurrence of AKI in infants admitted to the NICU;
时间窗: From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks
All available serum creatinine values for each patient during the NICU admission will be recorded, considering that determinations made within the first 48 hours of the infant's life are affected by maternal creatinine values. The presence of AKI will be determined according to the modified KIDGO criteria for the newborn, as reported in previous work in the neonatal setting (Jetton JG, 2017; Jetton JG and Askenazi DJ, 2012; Stoops C, 2016; Askenazi DJ, Patil NR, et al., 2015; Sarkar S, 2014).
Identify the drug or combination of drugs associated with an increased risk of AKI
时间窗: From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks
The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Special attention will be given to exposure to antibiotics, antivirals, antifungals, diuretics, anti-inflammatories, inotropes, and vasopressors. In addition to the active ingredient, other significant data such as prescribed dose, administration route, treatment duration, and temporal relationship between treatment and diagnosis of AKI will also be considered.
次要结局
- Identify subgroups of patients at increased risk of AKI(From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks)
- Identify time windows at increased risk of AKI during NICU admission.(From the date of randomization until the date of the first documented progression of AKI and up to 4 weeks)
研究者
Giacomo Cavallaro
Principal Investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico