Pulmonary Function Tests in Children and Adolescents With End Stage Renal Disease On Regular Hemodialysis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06106438
Collaborator
(none)
40
15

Study Details

Study Description

Brief Summary

to study pulmonary function tests in children with ESRD on regular HD and its correlation with dialysis duration and other various risk factors

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    End stage renal disease (ESRD) is irreversible and progressive disease which characterized by irreversible loss of kidney function. The ESRD is terminal and final pathway that resulted eventually in most of the patients suffering from medical problems affecting their renal function. Patients with ESRD need renal replacement therapy once they are established the ESRD stage via and that may either be achieved by dialysis (hemodialysis or peritoneal dialysis) or need kidney transplantation so as to be able to keep functioning normal renal life. There was an observed increase in the morbidity and mortality in ESRD patients because of the presence of the renal replacement therapy (HD or renal transplantation). Despite that ESRD may appear as a single organ dysfunction, it also affects multiple organs with variable and numerous complications which resulted in multi-organ dysfunction so the systemic complications presented in ESRD patients are very important .

    One of the most important of these complications is the respiratory system dysfunction related to renal dysfunction which is a very common complication in ESRD patients . Rising in the blood urea level, may be the cause that affects the respiratory system in the form of pulmonary edema, pleural effusion and acute respiratory distress syndrome (ARDS) .

    Dialysis may have beneficial effects at least in the initial stages of some respiratory disorders among CKD patients without primary lung disease. It may lead to improvement of respiratory symptoms and even pulmonary function test values.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Pulmonary Function Tests in Children and Adolescents With End Stage Renal Disease On Regular Hemodialysis
    Anticipated Study Start Date :
    Jan 1, 2024
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. pulmonary function tests [one year from january 2024 to december 2024]

      by spirometry including The forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), and FEV1/FVC ratio and forced expiratory flow (FEF) Pulmonary function tests will be measured before and after hemodialysis session

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Children and adolescents(more than seven years old and less than 18 years old) with ESRD on regular maintenance HD for at least six months before inclusion on the study
    Exclusion Criteria:
    • patients with age less than seven years or more than 18

    • patients with congenital heart diseases

    • patient with bronchial asthma

    • patient with musculoskeletal disorders

    • patient who were unable to cooperate

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Mohamed Mahrous El Tellawy, Professor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Dina Ahmed Mahmoud Othman, Assistant Lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06106438
    Other Study ID Numbers:
    • PFTs in children with ESRD
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 31, 2023