Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease

February 9, 2023 updated by: Wethab Khaled Mohamed, Sohag University

CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after

Study Overview

Status

Recruiting

Conditions

Predialytic Chronic Kidney Disease

Intervention / Treatment

Device: Holter

Detailed Description

This work aims to study the electrophysiological changes in cardiovascular system in children with predialytic CKD. ECG is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wethab K Mohamed, Pediatric resident
Phone Number: +2001090090162
Email: Wethab011226@med.sohag.edu.eg

Study Locations

Egypt
- - Sohag, Egypt
    - Recruiting
    - Sohag faculty of medicine
    - Contact:
      
      Magdy M Amin, professor
      
      Phone Number: (093)- 4602963
      
      Email: portal@med.sohag.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

children with predialytic chronic kidney disease

Description

Inclusion Criteria:

Age 1 to 15 year children with predialytic chronic kidney disease GFR.>15 ml\min per 1.73m2 , stages 1, 2, 3, 4 according to (KDOQI stages).

Exclusion Criteria:

Age >15 year On regular dialysis GFR<15 ml\min per 1.73m2, Stage 5 according to (KDOQI stages). Children with known cardiovascular disease or known arrhythmia Patients on the potential medication affecting ECG result as B-blocker, antipsychotics , antidepressant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability Time Frame: One year	Sinus tachycardia or bradycardia	One year
changes in QT interval Time Frame: One year	Prolonged QT interval in ECG	One year
QRS duration Time Frame: One year	Increase or decrease in ECG	One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)