- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06106438
Pulmonary Function Tests in Children and Adolescents With End Stage Renal Disease On Regular Hemodialysis
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dina Ahmed
- Phone Number: 01025750192
- Email: dina.ahmed682@yahoo.com
Study Contact Backup
- Name: Mohamed sayed, lecturer
- Phone Number: 01153999115
- Email: Mohamed000@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pulmonary function tests
Time Frame: 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
|
one year from january 2024 to december 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohamed Mahrous El Tellawy, Professor, Assiut University
Publications and helpful links
General Publications
- Bush A, Gabriel R. Pulmonary function in chronic renal failure: effects of dialysis and transplantation. Thorax. 1991 Jun;46(6):424-8. doi: 10.1136/thx.46.6.424.
- Navari K, Farshidi H, Pour-Reza-Gholi F, Nafar M, Zand S, Sohrab Pour H, Eqbal Eftekhaari T. Spirometry parameters in patients undergoing hemodialysis with bicarbonate and acetate dialysates. Iran J Kidney Dis. 2008 Jul;2(3):149-53.
- Senatore M, Buemi M, Di Somma A, Sapio C, Gallo GC. [Respiratory function abnormalities in uremic patients]. G Ital Nefrol. 2004 Jan-Feb;21(1):29-33. Italian.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PFTs in children with ESRD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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