Pulmonary Function Tests in Children and Adolescents With... | NCT06106438

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

NCT06106438

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

End Stage Renal Disease on Dialysis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

Oct 24, 2023

First Submission Date that Met QC Criteria

Oct 24, 2023

First Posted Date

Oct 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dina Ahmed	Contact	01025750192		dina.ahmed682@yahoo.com
Mohamed sayed, lecturer	Contact	01153999115		Mohamed000@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Mohamed Mahrous El Tellawy, Professor	Assiut University	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1858080	Background	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.
19377229	Background	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.