NCT06185257

Brief 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. 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.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

November 20, 2023

Last Update Submit

July 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Study Arms (3)

Patient with chronic kidney disease under dialysis

Device: EEG

Patients with nephrotic syndrome

Device: EEG

C. Normal control group

Device: EEG

Interventions

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

C. Normal control groupPatient with chronic kidney disease under dialysisPatients with nephrotic syndrome

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Electroencephalographic changes in nonconvulsive children with chronic renal disease

You may qualify if:

  • All children with chronic kidney disease and nephrotic syndrome

You may not qualify if:

  • Newborn
  • Patients with genetic disease Neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicNephrotic Syndrome

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNephrosis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

khloud A Saleh, Resident doctor

CONTACT

Mohamed M Eltellawy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal invistigator

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 29, 2023

Study Start

September 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 15, 2025

Last Updated

July 30, 2024

Record last verified: 2024-07