NCT06106438

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 24, 2023

Last Update Submit

October 29, 2023

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 1858080BACKGROUND

  • 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.

    PMID: 19377229BACKGROUND

  • 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.

    PMID: 15356844BACKGROUND

Related Links

Study Officials

  • Mohamed Mahrous El Tellawy, Professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Dina Ahmed

CONTACT

01025750192dina.ahmed682@yahoo.com

Mohamed sayed, lecturer

CONTACT

01153999115Mohamed000@aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10