Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury in newborn patients with congenital diaphragmatic hernia (CDH) (n=108)
研究概览
简要总结
The main aim of this project is to elucidate the incidence of acute kidney injury (AKI) in newborns with congenital diaphragmatic hernia during stay in the Pediatric intensive care unit. (PICU). This patient group often presents with severe circulatory and respiratory dysfunction requiring intensive care treatment. Characterization of risk factors to AKI will also be performed.
详细描述
There is an overwhelming number of studies showing that complication with acute kidney injury (AKI) in critically ill patients, including children and newborns results in increased morbidity and mortality. The more severe AKI, the higher risk of bad outcome. In the neonatal intensive care unit (NICU), the incidence of AKI is approximately 30 %, even higher in full-term babies (36 %).
Newborns with congenital diaphragmatic hernia (CDH) often present with severe cardio-respiratory dysfunction, often complicated by pulmonary hypertension (PPHN) requiring mechanical ventilation and vasoactive/inotropic drugs, especially during the first week in the intensive care. Some of these patients deteriorates and cannot maintain vital parameters despite conventional treatment and will therefore require extra corporeal membrane oxygenation). During the ICU-stay, the patients are subjected to several risk factors for developing AKI. Among physiological risk factors, PPHN, low oxygenation and blood pressure may result in renal dysfunction. Iatrogenic factors include the need for nephrotoxic drugs, not least antibiotics (Vancomycin, Gentamycin) and antimycotics. In addition, hyperchloremia may contribute to the development of AKI, since impaired renal blood flow is associated with hyperchloremia. The AKI incidence and its risk factors in CDH patients is not well studied.
The objectives of this well characterized retrospective cohort study is to establish AKI incidence in critically ill CDH-patients and investigate possible associations between risk factors and AKI (exposure to nephrotoxic drugs, degree of multiple organ failure, PPHN, vasoactive/inotropic requirement, oxygenation index, fluid overload and hyperchloremia) during PICU stay. The association of the risk factors to different stages of AKI will also be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Minute 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with congenital diaphragmatic hernia intubated and started invasive ventilation within 2 days.
排除标准
- •Invasive ventilation initiated after 2 days.
- •Severe comorbidity not compatible with life and/or not possible to correct surgically.
- •Death occurring within 2 days.
结局指标
主要结局
Incidence of acute kidney injury in newborn patients with congenital diaphragmatic hernia (CDH) (n=108)
时间窗: Acute kidney injury evolving during PICU-stay (from birth up to 10 weeks, which is the longest PICU-stay among the patients).)
Patients having or not having acute kidney injury will be determined by the score: neonatal Kidney Diseases: Improving Global Outcomes (n-KDIGO), based upon creatinine concentration (mikromoles/L). A 1.5-fold increase in creatinine concentration increase from first sampling will be classified as acute kidney injury.
次要结局
- Duration (days during first week in the PICU) of hyperchloremia(From birth up to one week in the. PICU.)
- Mortality during PICU-stay (max 10 weeks).(PICU-stay. (up to 10 weeks).)
- Use of nephrotoxic drugs(Given during PICU-stay (from birth up to 10 weeks))
- Development of multiple organ failure.(From birth up to one week in the PICU)
- Pulmonary hypertension(Developing during PICU-stay (from birth up to 10 weeks))
研究者
Urban Fläring
M.D. Ph.D. Associate Professor.
Karolinska Institutet