Evaluation of Volume Status Changes in Children on Regular Hemodialysis at Assiut University Children,s Hospital

Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months

Study Overview

• Status: Not yet recruiting
• Conditions: Volume Status in Chronic Kidney Diseases
• Intervention / Treatment: Device: lung ultrasonography

Detailed Description

Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months . The etiologies of CKD in children are three main groups of pathologies: congenital anomalies of the kidney and urinary tract , hereditary nephropathies and acquired causes . (2) complication of pediatric hemodialysis is chronic fluid overload, left ventricular hypertrophy ,hypertension, heart failure, decrease arterial flexibility and often results in increase chance of morbidity and mortality, So fluid overload must be prevented .(3) Lung ultrasonography is the most recent, safe, easy, and reliable technique . The most commonly observed finding is a comet tail fanning out from the lung-wall interface and spreading upwards to the edge of the screen, named a "B-line" Chest sonar advantages include its noninvasiveness , ease of use, availability of portable machines, avoidance of radiation detect lung edema even in initial non symptomatic cases known as hidden lung congestion .(4) Bioimpedance analysis (BIA) Bio impedance spectroscopy (BIS) is a technique used to estimate total body water, extracellular water, lean and adipose tissue mass and over hydration . (5) N-terminal pro-brain natriuretic peptide is used as a biomarker to aid to predict cardiac dysfunction in children and adolescents .(6)it is an effective marker of volume status in patient with or without reduced ejection fraction undergoing hemodialysis. (7)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ahlam Abdelbaset, MD; Phone Number: 01067815663; Email: Ahlam.Abdelbaset@med.aun.edu.eg
• Study Contact Backup: Name: Mohamed Mahrous, prof; Phone Number: 01003486595; Email: Eltelawy270@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All cases with end stage renal diseases undergoing regular haemodialysis in nephrology department in a period of two year

Description

Inclusion Criteria:

- Patients aged 3 to 16 years having end stage renal disease undergoing regular haemodialysis for at least more than 6 months of both gender were enrolled

Exclusion Criteria:

• Patients with chronic lung disease ,or pulmonary infection in the last 2 months were excluded from study.

Patients with congestive heart failure Patients with Pulmonary edema Patient with pericardial effusion parental refusal to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of volume status changes in children on regular hemodialysis at Assiut university children's hospital	Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar	two year

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: Professor Mohamed mahrous Eltallawy; Assistant Professor Ahlam Badawy Ali; Lecturer Asmaa Ahmed Mahmoud
• Investigators: Study Director: Ahlam Badawy, assist prof, Assiut University; Study Director: Asmaa Ahmed, Lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: volume status

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No