An observational study in Chronic Renal Disease and Nephrotic Syndrome, sponsored by Assiut University. Not yet recruiting. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Assiut University · Observational
Among 35 studies in Renal Insufficiency, Chronic by Assiut University — 25 open to participants now, 25 under way, 1 of them phase 3. Renal Insufficiency, Chronic · Assiut University.
Among the 35 studies in Renal Insufficiency, Chronic by Assiut University, this one is the 19th largest by planned enrollment of the 29 observational ones that give a count, is one of 9 that started in 2024, is one of 29 observational ones, reaches primary completion later than 0 of the 24 other live ones, and was the 13th registered.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
Browse Renal Insufficiency, Chronic studies →25 of the 35 studies in Renal Insufficiency, Chronic by Assiut University are open now, in 1 country. Recruiting first, the newest first:
Assiut University · Sites in Egypt
Assiut University
Assiut University · Sites in Egypt
Assiut University
Assiut University
By country, each count listing its studies:
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 6 Months to 18 Years · all sexes · no healthy volunteers.
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35 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 9 started in 2024.
This study's planned enrollment of 80 is below the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.
Median enrollment 99 across the 6 interventional studies, 100 across the 29 observational. None of them has completed or been terminated yet.
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Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
12 of the studies in Renal Insufficiency, Chronic by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07394920Assiut UniversityThe Role of Sodium Bicarbonate Enema in Improving Constipation and Reducing Uremic Toxins in Chronic Kidney Disease Patients. | 2027-03 |
| NCT06392425Assiut UniversityRole of Serum ADAM 17 (A Disintegrin And Metalloprotease 17) and Caspase 3 in Patients With Chronic Kidney Disease | 2027-03-31 |
| NCT07547852Assiut UniversityPleural Effusion Types in Chronic Kidney Disease | 2027-05 |
| NCT07805109Assiut UniversitySubclinical Renal Dysfunction in Rheumatoid Arthritis | 2027-09-01 |
| NCT07803237Assiut UniversityPredictors of Rapid CKD Progression | 2027-09-01 |
Among the 35 studies in Renal Insufficiency, Chronic by Assiut University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
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
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:
Electroencephalographic changes in nonconvulsive children with chronic renal disease
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Exclusion Criteria:
Device: EEG
Device: EEG
Device: EEG
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
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
Time frame: one year
No study locations are listed for this record.
Start is estimated for Sep 2024; primary completion for Jan 2025, 4 months later.
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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