NCT05549050

Brief Summary

This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.

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
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

July 8, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 17, 2022

Last Update Submit

September 29, 2022

Conditions

Keywords

interdialytic weight gaincardiovascularchronic kidney diseasehemodialysis

Outcome Measures

Primary Outcomes (1)

  • Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis

    Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis

    Through study completion, an average of 1 year

Interventions

interdialytic weight gain during hemodialysis

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

End-stage kidney disease children aged 2-18 years old

You may qualify if:

  • End-stage kidney disease (chronic kidney disease stage 5)
  • Undergo hemodialysis at least twice a week

You may not qualify if:

  • History of congenital heart disease
  • Critically ill patients with unstable hemodynamic status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Henny A Puspitasari, dr. Sp.A(K)

    Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henny A Puspitasari, dr. Sp.A(K)

CONTACT

Callen Zulkifli, dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Pediatric Nephrology

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 22, 2022

Study Start

July 8, 2022

Primary Completion

March 1, 2023

Study Completion

July 1, 2023

Last Updated

September 30, 2022

Record last verified: 2022-09

Locations