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临床试验/NCT06268314
NCT06268314尚未招募不适用

Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

Assiut University0 个研究点目标入组 70 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

研究概览

简要总结

To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease.

详细描述

Chronic kidney disease (CKD) is characterized by an irreversible deterioration of renal function that gradually progresses to end-stage renal disease. During the past 2 decades, the incidence of CKD in children has steadily increased.Children, adolescents, and young adults constitute less than 5% of the end-s population, and their 10-year survival ranges from 70% to 85%.Although children represent only a small proportion of all patients with CKD, affected children pose unique challenges to the health care system and to their providers, who must address not only the primary renal disorder, but the many extrarenal manifestations of CKD that complicate management.Serum albumin is a strong predictor for adverse outcomes in adults with chronic kidney disease (CKD). Because these conditions are amenable to treatments, recognition of hypoalbuminemia and underlying status may improve patient management, potentially leading to better clinical outcomes.Hypoalbuminemia is known to be an independent predictor of survival and hospitalization in adult patients with end-stage renal disease (ESRD) on dialysis.In children with ESRD, a few studies have focused on mortality or hospitalization as outcomes, showing the association of hypoalbuminemia with high mortality in incident dialysis patients and high hospitalization frequency in prevalent dialysis patients.Further, patients with chronic diseases and hypoalbuminemia lose fat-free mass, considered to be an essential indicator of the undernourished state, despite adequate food intake.Protein energy wasting (PEW) is common in patients with CKD and associated with adverse clinical Outcomes .(PEW) is closely associated with malnutrition and inflammation, where serum albumin is an established surrogate biomarker.

Children with CKD are also at high risk of poor nutrition and chronic inflammation .Malnutrition and inflammation are associated with adverse outcomes such as death or hospitalization.Furthermore, among children with CKD, inadequate nutrition is one of the most common causes of growth failure, resulting in short stature or low body mass index (BMI)which is also associated with death or hospitalization.

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
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The study will include patient on maintenance hemodialysis with hypoalbuminemia according to] Mites SedBuffone GJed Pediatric Clinical Chemistry. 3rd ed., Press(1989)[ (Hypoalbuminemia was defined as an albumin level of less than 3.4 g/dL for patients 7 months or older and less than 2.5 g/dL for patients younger than 7 months. ) who fulfilled the following criteria will be included in the study:
  • Age range from 2-16 years old.
  • Both sexes.
  • On maintenance hemodialysis with hypoalbuminemia

排除标准

  • other causes of hypoalbuminemia such as heart disease, diabetes mellitus , hepatic failure .
  • chronic kidney disease without hypoalbuminemia.

结局指标

主要结局

Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

时间窗: 2years

Feeding pattern has important role on improving hypoalbuminemia in pediatrics with chronic renal disease Based on determining the main outcome variable ,the estimated minimum required sample size is77. The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is the role of feeding in treating hypoalbuminemia in pediatric patients with CKD . Based on previous studies ( O.S. Catherine. et al. 2002 ) the percentage of patients of chronic kidney disease with hypoalbuminemia53.1% and based on the percentage confidence limits of 7% and a Confidence level =80

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Mohamed Abdel-Gawad

resident doctor

Assiut University

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