Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis

September 29, 2022 updated by: Henny Adriani Puspitasari, Indonesia University
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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

75

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

Study Contact Backup

Study Locations

    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo Hospital
        • Contact:

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

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis
Time Frame: Through study completion, an average of 1 year
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Henny A Puspitasari, dr. Sp.A(K), Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

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)

July 8, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

September 17, 2022

First Submitted That Met QC Criteria

September 17, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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