NCT05726071

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 13, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 31, 2023

Last Update Submit

February 9, 2023

Conditions

Predialytic Chronic Kidney Disease

Keywords

Chronic kidney disease

Outcome Measures

Primary Outcomes (3)

  • Heart rate variability

    Sinus tachycardia or bradycardia

    One year

  • changes in QT interval

    Prolonged QT interval in ECG

    One year

  • QRS duration

    Increase or decrease in ECG

    One year

Interventions

HolterDEVICE

24 hour electrocardiography

Also known as: ECG Fukuda Denshi CardiMax ECG device model FCP-7101

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children with predialytic chronic kidney disease

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Shafi S, Saleem M, Anjum R, Abdullah W, Shafi T. ECG Abnormalities In Patients With Chronic Kidney Disease. J Ayub Med Coll Abbottabad. 2017 Jan-Mar;29(1):61-64.

    PMID: 28712176BACKGROUND

  • Park S, Yum Y, Cha JJ, Joo HJ, Park JH, Hong SJ, Yu CW, Lim DS. Prevalence and Clinical Impact of Electrocardiographic Abnormalities in Patients with Chronic Kidney Disease. J Clin Med. 2022 Sep 15;11(18):5414. doi: 10.3390/jcm11185414.

    PMID: 36143060BACKGROUND

  • Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.

    PMID: 15241746BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Central Study Contacts

Wethab K Mohamed, Pediatric resident

CONTACT

+2001090090162Wethab011226@med.sohag.edu.eg

Shaimaa M Mahmoud, Assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric resident at El Helal Hospital

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 13, 2023

Study Start

November 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

February 13, 2023

Record last verified: 2023-01

Locations

EG(1)