End Stage Renal Disease on DialysisNCT06106438
Pulmonary Function Tests in Children and Adolescents With End Stage Renal Disease On Regular Hemodialysis
An observational study of End Stage Renal Disease on Dialysis, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
to study pulmonary function tests in children with ESRD on regular HD and its correlation with dialysis duration and other various risk factors
Read the 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.
- Conditions
- End Stage Renal Disease on Dialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year from january 2024 to december 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Mahmoud Othman, Assiut University
- Investigators
- Mohamed Mahrous El Tellawy, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106438
- Sponsor's protocol ID
- PFTs in children with ESRD
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 1858080Navari 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.
PubMed 19377229Senatore 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.
PubMed 15356844
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Tests in Children and Adolescents With End Stage Renal Disease On Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT06106438
- Acronym / sponsor ID
- PFTs in children with ESRD
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 1858080Bush 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.
- Background: PubMed 19377229Navari 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.
- Background: PubMed 15356844Senatore 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.
- Spirometric Parameters: Hemodialysis Compared to Peritoneal DialysisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Mahrous El Tellawy, Professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease on Dialysis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Ahmed (01025750192, dina.ahmed682@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function tests (time frame: one year from january 2024 to december 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106438, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.