A single center, observational study of renal replacement therapy in acute kidney injury in critically ill children
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Seth GS Medical College and KEM hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The study will comprehensively document and analyze the management of AKI patients requiring renal replacement therapy in PICU.
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 28.00 Day(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Infants and children,having AKI and undergoing renal replacement therapy will be included,only if the parents/patients are willing to participate.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The study will comprehensively document and analyze the management of AKI patients requiring renal replacement therapy in PICU.
Time Frame: Data will be analyzed at the end of the study
Secondary Outcomes
- The study will document morbidity and mortality of critically ill children with AKI(At the end of the study)
Investigators
Dr Mamta N Muranjan
Seth G.S. Medical College and KEM Hospital