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

NCT ID: NCT06194019

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-01

Brief Summary

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

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)

Conditions

Volume Status in Chronic Kidney Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

lung ultrasonography

N-terminal pro-brain natriuretic peptide (NT-proBNP) as a biomarker for detection volume overload.

Intervention Type: DEVICE

Other Intervention Names

Bioimpedance analysis (BIA)

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Professor Mohamed mahrous Eltallawy

UNKNOWN

Sponsor Role: collaborator

Assistant Professor Ahlam Badawy Ali

UNKNOWN

Sponsor Role: collaborator

Lecturer Asmaa Ahmed Mahmoud

UNKNOWN

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahlam Abelbaset Mohamed

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahlam Badawy, assist prof

Role: STUDY_DIRECTOR

Assiut University

Asmaa Ahmed, lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Ahlam Abdelbaset, MD

Role: CONTACT

Ahlam.Abdelbaset@med.aun.edu.eg

01067815663

Mohamed Mahrous, prof

Role: CONTACT

Eltelawy270@aun.edu.eg

01003486595

Other Identifiers

volume status

Identifier Type: -

Identifier Source: org_study_id