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

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06106438
• Other study ID #: PFTs in children with ESRD
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Dina Ahmed
• Phone: 01025750192
• Email: dina.ahmed682[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary function tests	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

External Links

•   Spirometric Parameters: Hemodialysis Compared to Peritoneal Dialysis