Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease.

NCT ID: NCT06268314

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-06-01

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Mohamed Abdel-Gawad

resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Elmenshawy

Role: STUDY_DIRECTOR

Assist university

Central Contacts

Mohamed Abdelguad, Resident

Role: CONTACT

ataay411@gmail.com

01023751005

Azaa Eltayib, Professor

Role: CONTACT

‪0100 686 3277‬

References

Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60.

Reference Type: BACKGROUND

PMID: 21629229 (View on PubMed)

Palmer SC, Maggo JK, Campbell KL, Craig JC, Johnson DW, Sutanto B, Ruospo M, Tong A, Strippoli GF. Dietary interventions for adults with chronic kidney disease. Cochrane Database Syst Rev. 2017 Apr 23;4(4):CD011998. doi: 10.1002/14651858.CD011998.pub2.

Reference Type: BACKGROUND

PMID: 28434208 (View on PubMed)

Iseki K, Uehara H, Nishime K, Tokuyama K, Yoshihara K, Kinjo K, Shiohira Y, Fukiyama K. Impact of the initial levels of laboratory variables on survival in chronic dialysis patients. Am J Kidney Dis. 1996 Oct;28(4):541-8. doi: 10.1016/s0272-6386(96)90465-5.

Reference Type: BACKGROUND

PMID: 8840944 (View on PubMed)

Wong CS, Hingorani S, Gillen DL, Sherrard DJ, Watkins SL, Brandt JR, Ball A, Stehman-Breen CO. Hypoalbuminemia and risk of death in pediatric patients with end-stage renal disease. Kidney Int. 2002 Feb;61(2):630-7. doi: 10.1046/j.1523-1755.2002.00169.x.

Reference Type: BACKGROUND

PMID: 11849406 (View on PubMed)

Rees L, Mak RH. Nutrition and growth in children with chronic kidney disease. Nat Rev Nephrol. 2011 Sep 27;7(11):615-23. doi: 10.1038/nrneph.2011.137.

Reference Type: BACKGROUND

PMID: 21947116 (View on PubMed)

Silverstein DM. Inflammation in chronic kidney disease: role in the progression of renal and cardiovascular disease. Pediatr Nephrol. 2009 Aug;24(8):1445-52. doi: 10.1007/s00467-008-1046-0. Epub 2008 Dec 13.

Reference Type: BACKGROUND

PMID: 19083024 (View on PubMed)

Rees L. 3.21 Nutritional management in children with chronic kidney disease. World Rev Nutr Diet. 2015;113:254-8. doi: 10.1159/000360347. Epub 2015 Apr 13. No abstract available.

Reference Type: BACKGROUND

PMID: 25906893 (View on PubMed)

Other Identifiers

hypoalbuminemia in pediatrics.

Identifier Type: -

Identifier Source: org_study_id