Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

Not yet recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT06268314
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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:

1. Age range from 2-16 years old.
2. Both sexes.
3. On maintenance hemodialysis with hypoalbuminemia

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.	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