Chronic Renal Disease and Nephrotic SyndromeNCT06185257
Electroencephalographic Changes in Nonconvulsive Children With Chronic Renal Disease
An observational study of Chronic Renal Disease and Nephrotic Syndrome, run by Assiut University.
Trial summary
Chronic kidney disease (CKD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. The diagnosis of CKD rests on establishing a chronic reduction in kidney function and structural kidney damage. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Chronic Renal Disease and Nephrotic Syndrome
- What is being tested?
- EEG
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Jan 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Electroencephalographic changes in nonconvulsive children with chronic renal disease
Who may be able to join
- All children with chronic kidney disease and nephrotic syndrome
Who cannot join
- Newborn
- Patients with genetic disease Neurological disorder
Trial locations and contacts
No sites are listed yet.
About this study
Chronic kidney disease (CKD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. The diagnosis of CKD rests on establishing a chronic reduction in kidney function and structural kidney damage. The best available indicator of overall kidney function is glomerular filtration rate (GFR), which equals the total amount of fluid filtered through all of the functioning nephrons per unit of time
The definition and classification of CKD have evolved over time, but current international guidelines define CKD as decreased kidney function shown by GFR of less than 60 mL/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of underlying cause . When GFR is less than 15 mL/min per 1·73m2 , a person has reached end stage kidney disease (ESKD), at which point kidney function is no longer able to sustain life over the long term. Options for patients with ESKD are kidney replacement therapy (in the form of dialysis or kidney transplantation), or conservative care (also called palliation or non-dialytic care
Read more
Encephalopathy detected in patients with chronic kidney disease results from their exposure to several factors, such as uremia, hypertension, and fluid, and electrolyte disturbances (Brouns R, DyDeyn pp,2004)
Uremic encephalopathy features include alterations of mental status (alertness and awareness alterations, poor concentration, psychosis, and hallucinations, without treatment of which stupor, and coma may develop) and motor system abnormalities, such as clouding of the sensorium as an early feature and delirium, seizures, and coma as late features (Palmer sc ,etal,2010)EEG is useful in assessing patients in uremic encephalopathy and in monitoring their progress. Electroencephalographic (EEG) findings correlate with clinical symptoms and, therefore, may be of diagnostic value. In addition, it can be useful to exclude other causes of confusion such as infection or structural abnormalities (Dijck Annemie Van,etal,2012).
The EEG in uremic encephalopathy is generally abnormal, showing generalized slowing that becomes more severe as the condition worsens. EEG in CKD usually shows irregular low voltage with slowing of the posterior dominant alpha rhythm and occasional theta bursts. Prolonged bursts of bilateral, synchronous slow and sharp waves or spike and waves are characteristic. These changes stabilize with dialysis. EEG abnormalities in uremic encephalopathy is reflected through appearance of theta waves, disappearance of normal basic rhythms and diminished reactivity of EEG to afferent stimulation and domination by generalized delta activity. All these changes are mostly appreciated in the frontal leads (Al Arieff,Philadelphia,Ssaunders,2004)(Cl fraser, Arieff,Philadelphia,2001)
A lot of studies have been done about uremic encephalopathy in acute renal failure patients. Very few data are available regarding EEG changes in CKD. This study evaluates the EEG findings in different stages of CKD.
Read the detailed description
Aim of the study Evaluate electroencephalographic changes in children with chronic renal disease and nephrotic syndrome
Patient and Method include :
Methodology Subjects selected are divided into 3 groups A. Patient with chronic kidney disease under dialysis B. Patients with nephrotic syndrome
- Patients in remission
- Patients relapse C. Normal control group
Detailed history including age, sex , residence ,complain, renal symptoms will be taken.
Detailed examination, lab investigations, and treatment will be recorded
Imaging ( EEG) , results of the three groups will be assessed and compared and lab investigation ( lipid profile of all patients) will be measured
TYPE OF THE STUDY
Observational study
Sitting of the study
Assiut University children hospital Inclusion criteria
All children with chronic kidney disease and nephrotic syndrome
Exclusion criteria
- Newborn
- Patients with genetic disease Neurological disorder
Sample size Based on determining the main outcome variable, the estimated minimal required sample size is 102 patient (34 patient in each group).the sample was calculated using Gpower software 3.1.9.2.,based on the following assumptions: main outcome variable is the deference in the main value of relative power of delta band of patients with chronic kidney disease ,patients with nephrotic syndrome, and normal control group. based on clinical experience we expected to find large effect size difference between the 3 groups .main statistical test is independent t-test to detect the difference between the 3 groups Alpha=.05 Power=.95 Effect size=1.1
Statistical analysis
All statistical analysis will be performed by SPSS version 20. Mean and standard deviation will be used for descriptive statistics . for quantitative data
Ethical considerations:
- risk-benefit ratio The EEG has been used for many years and is considered a safe procedure. The test causes no discomfort. The electrodes record activity. They do not produce any sensation. In addition, there is no risk of getting an electric shock.
- confidenity Any data taken from the patient either from history the examination or the investigations will be very confidential
- researsh statement Every patient subjected to this study will be informed about the procedure of the research
- informed consent The aim of our investigation will be explained to all parents and informed written consent was taken as well • Other ethical concerns The research will be conducted only by scientifically qualified and trained personnel
- Being tested
- EEG
- Medical subject headings
- Renal Insufficiency, Chronic, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
Methodology Subjects selected are divided into 3 groups A. Patient with chronic kidney disease under dialysis B. Patients with nephrotic syndrome
- Patients in remission
- Patients relapse C. Normal control group
Detailed history including age, sex , residence ,complain, renal symptoms will be taken.
Detailed examination, lab investigations, and treatment will be recorded
Imaging ( EEG) , results of the three groups will be assessed and compared and lab investigation ( lipid profile of all patients) will be measured
| Study group | Role | What they receive |
|---|---|---|
| Patient with chronic kidney disease under dialysis | Not described Receives: Device: EEG | |
| Patients with nephrotic syndrome | Not described Receives: Device: EEG | |
| C. Normal control group | Not described Receives: Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalographic changes in non convulsive children with chronic renal disease
Evaluate electroencephalographic changes in children with chronic renal disease and Under dialysis and without dialysis changes in wave form , amplitude of waves , symmetry,sharp waves present or not in EEG compared to normal children Under dialysis and without dialysis as wave changes in EEG compared to normal children
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start15 Sep 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal Disease and Nephrotic SyndromeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khloud Abd-elnasser Saleh Seif, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185257
- Sponsor's protocol ID
- Electroencephalographic change
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Changes in Nonconvulsive Children With Chronic Renal Disease
- ClinicalTrials.gov ID
- NCT06185257
- Acronym / sponsor ID
- Electroencephalographic change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 29 Dec 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.
Chronic kidney disease (CKD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. The diagnosis of CKD rests on establishing a chronic reduction in kidney function and structural kidney damage. The best available indicator of overall kidney function is glomerular filtration rate (GFR), which equals the total amount of fluid filtered through all of the functioning nephrons per unit of time
The definition and classification of CKD have evolved over time, but current international guidelines define CKD as decreased kidney function shown by GFR of less than 60 mL/min per 1·73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of underlying cause . When GFR is less than 15 mL/min per 1·73m2 , a person has reached end stage kidney disease (ESKD), at which point kidney function is no longer able to sustain life over the long term. Options for patients with ESKD are kidney replacement therapy (in the form of dialysis or kidney transplantation), or conservative care (also called palliation or non-dialytic care
Encephalopathy detected in patients with chronic kidney disease results from their exposure to several factors, such as uremia, hypertension, and fluid, and electrolyte disturbances (Brouns R, DyDeyn pp,2004)
Uremic encephalopathy features include alterations of mental status (alertness and awareness alterations, poor concentration, psychosis, and hallucinations, without treatment of which stupor, and coma may develop) and motor system abnormalities, such as clouding of the sensorium as an early feature and delirium, seizures, and coma as late features (Palmer sc ,etal,2010)EEG is useful in assessing patients in uremic encephalopathy and in monitoring their progress. Electroencephalographic (EEG) findings correlate with clinical symptoms and, therefore, may be of diagnostic value. In addition, it can be useful to exclude other causes of confusion such as infection or structural abnormalities (Dijck Annemie Van,etal,2012).
The EEG in uremic encephalopathy is generally abnormal, showing generalized slowing that becomes more severe as the condition worsens. EEG in CKD usually shows irregular low voltage with slowing of the posterior dominant alpha rhythm and occasional theta bursts. Prolonged bursts of bilateral, synchronous slow and sharp waves or spike and waves are characteristic. These changes stabilize with dialysis. EEG abnormalities in uremic encephalopathy is reflected through appearance of theta waves, disappearance of normal basic rhythms and diminished reactivity of EEG to afferent stimulation and domination by generalized delta activity. All these changes are mostly appreciated in the frontal leads (Al Arieff,Philadelphia,Ssaunders,2004)(Cl fraser, Arieff,Philadelphia,2001)
A lot of studies have been done about uremic encephalopathy in acute renal failure patients. Very few data are available regarding EEG changes in CKD. This study evaluates the EEG findings in different stages of CKD.
Detailed description
Aim of the study Evaluate electroencephalographic changes in children with chronic renal disease and nephrotic syndrome
Patient and Method include :
Methodology Subjects selected are divided into 3 groups A. Patient with chronic kidney disease under dialysis B. Patients with nephrotic syndrome
- Patients in remission
- Patients relapse C. Normal control group
Detailed history including age, sex , residence ,complain, renal symptoms will be taken.
Detailed examination, lab investigations, and treatment will be recorded
Imaging ( EEG) , results of the three groups will be assessed and compared and lab investigation ( lipid profile of all patients) will be measured
TYPE OF THE STUDY
Observational study
Sitting of the study
Assiut University children hospital Inclusion criteria
All children with chronic kidney disease and nephrotic syndrome
Exclusion criteria
- Newborn
- Patients with genetic disease Neurological disorder
Sample size Based on determining the main outcome variable, the estimated minimal required sample size is 102 patient (34 patient in each group).the sample was calculated using Gpower software 3.1.9.2.,based on the following assumptions: main outcome variable is the deference in the main value of relative power of delta band of patients with chronic kidney disease ,patients with nephrotic syndrome, and normal control group. based on clinical experience we expected to find large effect size difference between the 3 groups .main statistical test is independent t-test to detect the difference between the 3 groups Alpha=.05 Power=.95 Effect size=1.1
Statistical analysis
All statistical analysis will be performed by SPSS version 20. Mean and standard deviation will be used for descriptive statistics . for quantitative data
Ethical considerations:
- risk-benefit ratio The EEG has been used for many years and is considered a safe procedure. The test causes no discomfort. The electrodes record activity. They do not produce any sensation. In addition, there is no risk of getting an electric shock.
- confidenity Any data taken from the patient either from history the examination or the investigations will be very confidential
- researsh statement Every patient subjected to this study will be informed about the procedure of the research
- informed consent The aim of our investigation will be explained to all parents and informed written consent was taken as well • Other ethical concerns The research will be conducted only by scientifically qualified and trained personnel
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic kidney disease under dialysis | – | Device: EEG |
| Patients with nephrotic syndrome | – | Device: EEG |
| C. Normal control group | – | Device: EEG |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Electroencephalographic changes in nonconvulsive children with chronic renal disease
Key inclusion criteria (1 listed)
- All children with chronic kidney disease and nephrotic syndrome
Key exclusion criteria (2 listed)
- Newborn
- Patients with genetic disease Neurological disorder
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 |
|---|---|---|
| EEGMethodology Subjects selected are divided into 3 groups A. Patient with chronic kidney disease under dialysis B. Patients with nephrotic syndrome * Patients in remission * Patients relapse C. Normal control group Detailed history including age, sex , residence ,complain, renal symptoms will be taken. Detailed examination, lab investigations, and treatment will be recorded Imaging ( EEG) , results of the three groups will be assessed and compared and lab investigation ( lipid profile of all patients) will be measured | Device | C. Normal control group, Patient with chronic kidney disease under dialysis, Patients with nephrotic syndrome |
Primary outcome
Electroencephalographic changes in non convulsive children with chronic renal disease
Time frame: one year
Evaluate electroencephalographic changes in children with chronic renal disease and Under dialysis and without dialysis changes in wave form , amplitude of waves , symmetry,sharp waves present or not in EEG compared to normal children Under dialysis and without dialysis as wave changes in EEG compared to normal children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Disease and Nephrotic Syndrome, 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 30 Jul 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 khloud A Saleh, Resident doctor (+201122958648, smartkhloud2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalographic changes in non convulsive children with chronic renal disease (time frame: one 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 30 Jul 2024.