A single center, observational study of renal replacement therapy in acute kidney injury in critically ill children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The study will comprehensively document and analyze the management of AKI patients requiring renal replacement therapy in PICU.
研究概览
简要总结
The observational study focuses on renal replacement therapy (RRT) in critically ill children with acute kidney injury (AKI), utilizing a single-center approach to examine clinical outcomes and management strategies. AKI, characterized by acute renal failure lasting hours to days, poses significant challenges in pediatric intensive care, affecting approximately 5% of hospitalized children and 32% of those in pediatric intensive care units. Renal replacement therapies such as hemodialysis (HD) and peritoneal dialysis (PD) play critical roles in managing severe cases, addressing complications like refractory hyperkalemia, oliguria, acidosis, and uremia.
The study aims to explore the efficacy and safety profiles of different RRT modalities, including HD variants like continuous renal replacement therapy (CRRT) and sustained low-efficiency dialysis (SLED). It seeks to identify predictors of survival and renal recovery in severe AKI (stage 3) among pediatric patients, considering factors such as underlying conditions, sepsis, electrolyte imbalances, and mechanical ventilation requirements.
Methodologically, the study employs an ambispective observational design, integrating prospective and retrospective data over a period of 3 years, with a targeted enrollment of 70 participants. Ethical considerations ensure adherence to institutional guidelines, including informed consent and patient confidentiality. Data collection encompasses detailed clinical parameters, RRT specifics, and outcomes such as mortality rates and renal function recovery post-treatment.
Statistical analyses will encompass descriptive statistics to profile the study cohort, comparative analyses of RRT modalities, survival analysis using Kaplan-Meier curves, and subgroup analyses to explore treatment effect modifiers. This comprehensive approach aims to yield insights into optimizing RRT practices and improving outcomes for critically ill children with AKI, ultimately informing evidence-based guidelines and enhancing pediatric nephrology care strategies.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 28.00 Day(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Infants and children,having AKI and undergoing renal replacement therapy will be included,only if the parents/patients are willing to participate.
排除标准
- •Patients who have received renal replacement therapy in another institute and are recovering during their stay at study site will be excluded and patients with end stage renal disease esta blished on RRT will be excluded.
结局指标
主要结局
The study will comprehensively document and analyze the management of AKI patients requiring renal replacement therapy in PICU.
时间窗: Data will be analyzed at the end of the study
次要结局
- The study will document morbidity and mortality of critically ill children with AKI(At the end of the study)
研究者
Dr Mamta N Muranjan
Seth G.S. Medical College and KEM Hospital