Volume Status in Chronic Kidney DiseasesNCT06194019
Evaluation of Volume Status Changes in Children on Regular Hemodialysis at Assiut University Children,s Hospital
An observational study of Volume Status in Chronic Kidney Diseases, run by Assiut University.
Trial summary
Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Volume Status in Chronic Kidney Diseases
- What is being tested?
- lung ultrasonography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2026
- 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 3 to 18 years
- All sexes
- Child, Adult
Study population: All cases with end stage renal diseases undergoing regular haemodialysis in nephrology department in a period of two year
Who may be able to join
- Patients aged 3 to 16 years having end stage renal disease undergoing regular haemodialysis for at least more than 6 months of both gender were enrolled
Who cannot join
- Patients with chronic lung disease ,or pulmonary infection in the last 2 months were excluded from study.
- Patients with congestive heart failure Patients with Pulmonary edema Patient with pericardial effusion parental refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months
Read the detailed description
Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months . The etiologies of CKD in children are three main groups of pathologies: congenital anomalies of the kidney and urinary tract , hereditary nephropathies and acquired causes . (2) complication of pediatric hemodialysis is chronic fluid overload, left ventricular hypertrophy ,hypertension, heart failure, decrease arterial flexibility and often results in increase chance of morbidity and mortality, So fluid overload must be prevented .(3) Lung ultrasonography is the most recent, safe, easy, and reliable technique . The most commonly observed finding is a comet tail fanning out from the lung-wall interface and spreading upwards to the edge of the screen, named a "B-line" Chest sonar advantages include its noninvasiveness , ease of use, availability of portable machines, avoidance of radiation detect lung edema even in initial non symptomatic cases known as hidden lung congestion .(4) Bioimpedance analysis (BIA) Bio impedance spectroscopy (BIS) is a technique used to estimate total body water, extracellular water, lean and adipose tissue mass and over hydration . (5) N-terminal pro-brain natriuretic peptide is used as a biomarker to aid to predict cardiac dysfunction in children and adolescents .(6)it is an effective marker of volume status in patient with or without reduced ejection fraction undergoing hemodialysis. (7)
- Conditions
- Volume Status in Chronic Kidney Diseases
- Being tested
- lung ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasonographyDevice
Also called Bioimpedance analysis (BIA)
N-terminal pro-brain natriuretic peptide (NT-proBNP) as a biomarker for detection volume overload.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of volume status changes in children on regular hemodialysis at Assiut university children's hospital
Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar
Evaluation of Volume status in children on regular haemodialysis by Chest sonar
Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume Status in Chronic Kidney DiseasesStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Professor Mohamed mahrous Eltallawy, Assistant Professor Ahlam Badawy Ali, Lecturer Asmaa Ahmed Mahmoud
- Responsible party
- Principal investigator, Ahlam Abelbaset Mohamed, Assiut University
- Investigators
- Ahlam Badawy, assist prof, Study director, Assiut UniversityAsmaa Ahmed, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194019
- Sponsor's protocol ID
- volume status
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Volume Status Changes in Children on Regular Hemodialysis at Assiut University Children,s Hospital
- ClinicalTrials.gov ID
- NCT06194019
- Acronym / sponsor ID
- volume status
- Conditions
- Volume Status in Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Professor Mohamed mahrous Eltallawy, Assistant Professor Ahlam Badawy Ali, Lecturer Asmaa Ahmed Mahmoud
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 8 Jan 2024 (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.
Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months
Detailed description
Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months . The etiologies of CKD in children are three main groups of pathologies: congenital anomalies of the kidney and urinary tract , hereditary nephropathies and acquired causes . (2) complication of pediatric hemodialysis is chronic fluid overload, left ventricular hypertrophy ,hypertension, heart failure, decrease arterial flexibility and often results in increase chance of morbidity and mortality, So fluid overload must be prevented .(3) Lung ultrasonography is the most recent, safe, easy, and reliable technique . The most commonly observed finding is a comet tail fanning out from the lung-wall interface and spreading upwards to the edge of the screen, named a "B-line" Chest sonar advantages include its noninvasiveness , ease of use, availability of portable machines, avoidance of radiation detect lung edema even in initial non symptomatic cases known as hidden lung congestion .(4) Bioimpedance analysis (BIA) Bio impedance spectroscopy (BIS) is a technique used to estimate total body water, extracellular water, lean and adipose tissue mass and over hydration . (5) N-terminal pro-brain natriuretic peptide is used as a biomarker to aid to predict cardiac dysfunction in children and adolescents .(6)it is an effective marker of volume status in patient with or without reduced ejection fraction undergoing hemodialysis. (7)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All cases with end stage renal diseases undergoing regular haemodialysis in nephrology department in a period of two year
Key inclusion criteria (1 listed)
- Patients aged 3 to 16 years having end stage renal disease undergoing regular haemodialysis for at least more than 6 months of both gender were enrolled
Key exclusion criteria (2 listed)
- Patients with chronic lung disease ,or pulmonary infection in the last 2 months were excluded from study.
- Patients with congestive heart failure Patients with Pulmonary edema Patient with pericardial effusion parental refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasonographyAlso: Bioimpedance analysis (BIA)N-terminal pro-brain natriuretic peptide (NT-proBNP) as a biomarker for detection volume overload. | Device | – |
Primary outcome
Evaluation of volume status changes in children on regular hemodialysis at Assiut university children's hospital
Time frame: two year
Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Volume Status in Chronic Kidney Diseases
Not yet recruitingObservational study
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD)
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.
Ahlam Badawy, assist prof study director
Assiut University
Asmaa Ahmed, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Volume Status in Chronic Kidney Diseases, 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 2 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 17 Jan 2024. 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 Ahlam Abdelbaset, MD (01067815663, Ahlam.Abdelbaset@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of volume status changes in children on regular hemodialysis at Assiut university children's hospital (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2024.